Trial Outcomes & Findings for On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay (NCT NCT02391948)
NCT ID: NCT02391948
Last Updated: 2019-04-19
Results Overview
The ECAB addresses postural control and balance across the developmental sequence. Part I has 7 items (with numbers 1,4,5,6,7 scored bilaterally): 1) lateral head righting, 2) head righting in extension, 3) head righting in flexion, 4) rotation in the trunk, 5) equilibrium reactions in sitting, 6) protective extension to the side, and 7) protective extension backwards. The items are scored on a scale of 0 = no response to 3 = complete \& consistent response. Part II has 6 items: 1) sitting with back unsupported but feet supported, 2) moving from sitting to standing, 3) standing unsupported with eyes closed, 4) standing unsupported with feet together, 5) turning 360 degrees in standing unsupported, 6) placing alternate foot on the step while standing unsupported. These items are scored on a variable scale, which is weighted due to the increased difficulty of the items. Part I and Part II item scores are summed for a total score between 0-100. A higher score represents better balance.
Recruitment status
COMPLETED
Target enrollment
724 participants
Primary outcome timeframe
up to 24-months
Results posted on
2019-04-19
Participant Flow
Study Population: Children with cerebral palsy of gross motor delay, ages 18 month to 11 years, and their parents. Sampling Method: Non-Probability Sample. Participants Recruited for 2-Visit or 5-Visit Study.
N=724 participants agreed to participate in the study following completion of the informed consent process. The number of participants "Started" (N=708) is different from the number of participants "Enrolled" (N=724) because N=16 were Enrolled, and Not Started for the following Reasons: Death = 1. Lost to Follow-up = 4. Ineligible = 11.
Participant milestones
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Baseline
STARTED
|
227
|
161
|
80
|
129
|
111
|
|
Baseline
COMPLETED
|
227
|
161
|
80
|
129
|
111
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
6-month Assessment
STARTED
|
227
|
161
|
80
|
129
|
111
|
|
6-month Assessment
COMPLETED
|
148
|
105
|
49
|
84
|
85
|
|
6-month Assessment
NOT COMPLETED
|
79
|
56
|
31
|
45
|
26
|
|
12-month Assessment
STARTED
|
225
|
156
|
77
|
125
|
109
|
|
12-month Assessment
COMPLETED
|
217
|
147
|
73
|
116
|
103
|
|
12-month Assessment
NOT COMPLETED
|
8
|
9
|
4
|
9
|
6
|
|
18-month Assessment
STARTED
|
219
|
151
|
74
|
119
|
105
|
|
18-month Assessment
COMPLETED
|
147
|
101
|
48
|
83
|
75
|
|
18-month Assessment
NOT COMPLETED
|
72
|
50
|
26
|
36
|
30
|
|
24-month Assessment
STARTED
|
149
|
107
|
51
|
84
|
79
|
|
24-month Assessment
COMPLETED
|
135
|
97
|
48
|
75
|
69
|
|
24-month Assessment
NOT COMPLETED
|
14
|
10
|
3
|
9
|
10
|
Reasons for withdrawal
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
6-month Assessment
Death
|
0
|
0
|
0
|
0
|
1
|
|
6-month Assessment
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
0
|
|
6-month Assessment
Lost to Follow-up
|
4
|
5
|
2
|
3
|
1
|
|
6-month Assessment
Medical issue/illness
|
1
|
1
|
0
|
0
|
0
|
|
6-month Assessment
Not able to schedule visit in timeframe
|
6
|
8
|
4
|
5
|
0
|
|
6-month Assessment
In 2-visit study (6-month N/A)
|
68
|
42
|
24
|
35
|
24
|
|
12-month Assessment
Death
|
0
|
0
|
0
|
1
|
0
|
|
12-month Assessment
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
|
12-month Assessment
Lost to Follow-up
|
5
|
4
|
4
|
4
|
5
|
|
12-month Assessment
Medical issue/illness
|
0
|
1
|
0
|
1
|
0
|
|
12-month Assessment
Not able to schedule visit in timeframe
|
2
|
4
|
0
|
2
|
1
|
|
18-month Assessment
Death
|
0
|
0
|
0
|
1
|
1
|
|
18-month Assessment
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
|
18-month Assessment
Lost to Follow-up
|
2
|
6
|
2
|
2
|
3
|
|
18-month Assessment
Not able to schedule visit in timeframe
|
3
|
3
|
2
|
1
|
4
|
|
18-month Assessment
In 2-visit study (18- and 24-month N/A)
|
66
|
41
|
22
|
31
|
22
|
|
24-month Assessment
Death
|
0
|
0
|
0
|
0
|
1
|
|
24-month Assessment
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
1
|
|
24-month Assessment
Lost to Follow-up
|
5
|
4
|
0
|
0
|
0
|
|
24-month Assessment
Medical issue/illness
|
0
|
0
|
1
|
0
|
0
|
|
24-month Assessment
Not able to schedule visit in timeframe
|
8
|
5
|
2
|
9
|
8
|
Baseline Characteristics
On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay
Baseline characteristics by cohort
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
Total
n=708 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
214 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
654 Participants
n=8 Participants
|
|
Age, Continuous
Age in Months at Baseline
|
70.1 months
STANDARD_DEVIATION 33.5 • n=5 Participants
|
75.6 months
STANDARD_DEVIATION 31.2 • n=7 Participants
|
71.3 months
STANDARD_DEVIATION 31.5 • n=5 Participants
|
69.6 months
STANDARD_DEVIATION 29.5 • n=4 Participants
|
75.2 months
STANDARD_DEVIATION 34.3 • n=21 Participants
|
72.2 months
STANDARD_DEVIATION 32.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
312 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
396 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
170 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
503 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
81 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
121 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
347 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
106 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
361 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).
The ECAB addresses postural control and balance across the developmental sequence. Part I has 7 items (with numbers 1,4,5,6,7 scored bilaterally): 1) lateral head righting, 2) head righting in extension, 3) head righting in flexion, 4) rotation in the trunk, 5) equilibrium reactions in sitting, 6) protective extension to the side, and 7) protective extension backwards. The items are scored on a scale of 0 = no response to 3 = complete \& consistent response. Part II has 6 items: 1) sitting with back unsupported but feet supported, 2) moving from sitting to standing, 3) standing unsupported with eyes closed, 4) standing unsupported with feet together, 5) turning 360 degrees in standing unsupported, 6) placing alternate foot on the step while standing unsupported. These items are scored on a variable scale, which is weighted due to the increased difficulty of the items. Part I and Part II item scores are summed for a total score between 0-100. A higher score represents better balance.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Early Clinical Assessment of Balance (ECAB)
6-month assessment: 6 years and older
|
97.4 units on a scale
Standard Deviation 5.2
|
86.1 units on a scale
Standard Deviation 16.9
|
49.0 units on a scale
Standard Deviation 17.0
|
24.8 units on a scale
Standard Deviation 11.9
|
7.2 units on a scale
Standard Deviation 6.6
|
|
Early Clinical Assessment of Balance (ECAB)
12-month assessment: under 6 years
|
86.3 units on a scale
Standard Deviation 14.3
|
64.9 units on a scale
Standard Deviation 20.8
|
37.5 units on a scale
Standard Deviation 7.9
|
26.3 units on a scale
Standard Deviation 7.9
|
7.6 units on a scale
Standard Deviation 6.3
|
|
Early Clinical Assessment of Balance (ECAB)
12-month assessment: 6 years and older
|
98.1 units on a scale
Standard Deviation 4.4
|
86.9 units on a scale
Standard Deviation 15.8
|
50.6 units on a scale
Standard Deviation 19.0
|
25.0 units on a scale
Standard Deviation 10.9
|
8.0 units on a scale
Standard Deviation 7.9
|
|
Early Clinical Assessment of Balance (ECAB)
18-month assessment: under 6 years
|
86.6 units on a scale
Standard Deviation 15.1
|
62.8 units on a scale
Standard Deviation 18.9
|
41.4 units on a scale
Standard Deviation 12.3
|
29.3 units on a scale
Standard Deviation 8.2
|
7.7 units on a scale
Standard Deviation 7.1
|
|
Early Clinical Assessment of Balance (ECAB)
18-month assessment: 6 years and older
|
97.9 units on a scale
Standard Deviation 4.8
|
86.9 units on a scale
Standard Deviation 16.5
|
52.6 units on a scale
Standard Deviation 19.9
|
25.9 units on a scale
Standard Deviation 11.7
|
7.4 units on a scale
Standard Deviation 6.9
|
|
Early Clinical Assessment of Balance (ECAB)
24-month assessment: under 6 years
|
89.8 units on a scale
Standard Deviation 14.5
|
62.2 units on a scale
Standard Deviation 17.8
|
40.7 units on a scale
Standard Deviation 11.6
|
28.5 units on a scale
Standard Deviation 8.0
|
7.1 units on a scale
Standard Deviation 6.2
|
|
Early Clinical Assessment of Balance (ECAB)
24-month assessment: 6 years and older
|
98.4 units on a scale
Standard Deviation 3.7
|
87.0 units on a scale
Standard Deviation 16.1
|
54.3 units on a scale
Standard Deviation 21.9
|
24.9 units on a scale
Standard Deviation 10.9
|
7.1 units on a scale
Standard Deviation 6.1
|
|
Early Clinical Assessment of Balance (ECAB)
Baseline: under 6 years
|
79.4 units on a scale
Standard Deviation 19.6
|
61.1 units on a scale
Standard Deviation 19.2
|
38.0 units on a scale
Standard Deviation 14.8
|
23.0 units on a scale
Standard Deviation 8.8
|
7.3 units on a scale
Standard Deviation 5.1
|
|
Early Clinical Assessment of Balance (ECAB)
Baseline: 6 years and older
|
97.4 units on a scale
Standard Deviation 5.1
|
86.0 units on a scale
Standard Deviation 15.8
|
44.3 units on a scale
Standard Deviation 14.3
|
24.7 units on a scale
Standard Deviation 10.0
|
6.4 units on a scale
Standard Deviation 6.8
|
|
Early Clinical Assessment of Balance (ECAB)
6-month assessment: under 6 years
|
80.4 units on a scale
Standard Deviation 18.9
|
61.6 units on a scale
Standard Deviation 19.8
|
37.6 units on a scale
Standard Deviation 12.7
|
26.1 units on a scale
Standard Deviation 8.4
|
8.1 units on a scale
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).
The SAROMM addresses joint range of motion, extensibility, and spinal alignment. The Spinal Alignment Subscale contains 4 items and the Range of Motion and Extensibility Subscale has 22 items. Each item is scored on a 5-point Likert scale, with 0 = normal alignment and range with active correction, 1 = normal alignment and range with passive correction, and 2, 3, and 4 indicating fixed deformities or contractures that are "mild", "moderate", or "severe" based on pre-specified cut points, and supported by photographs in the training manual. Scores are reported by calculating the average of scores across all 26 items. Scores range from 0-4. A lower score represents better range of motion and alignment.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
Baseline: under 6 years
|
0.3 units on a scale
Standard Deviation 0.3
|
0.6 units on a scale
Standard Deviation 0.4
|
0.9 units on a scale
Standard Deviation 0.4
|
1.1 units on a scale
Standard Deviation 0.5
|
1.4 units on a scale
Standard Deviation 0.5
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
Baseline: 6 years and older
|
0.4 units on a scale
Standard Deviation 0.3
|
0.6 units on a scale
Standard Deviation 0.4
|
1.0 units on a scale
Standard Deviation 0.5
|
1.5 units on a scale
Standard Deviation 0.6
|
1.9 units on a scale
Standard Deviation 0.6
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
6-month assessment: under 6 years
|
0.3 units on a scale
Standard Deviation 0.3
|
0.6 units on a scale
Standard Deviation 0.4
|
0.8 units on a scale
Standard Deviation 0.3
|
1.0 units on a scale
Standard Deviation 0.6
|
1.2 units on a scale
Standard Deviation 0.6
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
6-month assessment: 6 years and older
|
0.4 units on a scale
Standard Deviation 0.3
|
0.6 units on a scale
Standard Deviation 0.4
|
0.8 units on a scale
Standard Deviation 0.4
|
1.3 units on a scale
Standard Deviation 0.6
|
1.9 units on a scale
Standard Deviation 0.6
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
12-month assessment: under 6 years
|
0.3 units on a scale
Standard Deviation 0.2
|
0.6 units on a scale
Standard Deviation 0.4
|
0.8 units on a scale
Standard Deviation 0.4
|
1.1 units on a scale
Standard Deviation 0.5
|
1.4 units on a scale
Standard Deviation 0.6
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
12-month assessment: 6 years and older
|
0.4 units on a scale
Standard Deviation 0.3
|
0.6 units on a scale
Standard Deviation 0.4
|
0.9 units on a scale
Standard Deviation 0.4
|
1.3 units on a scale
Standard Deviation 0.5
|
2.0 units on a scale
Standard Deviation 0.6
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
18-month assessment: under 6 years
|
0.3 units on a scale
Standard Deviation 0.3
|
0.6 units on a scale
Standard Deviation 0.4
|
0.8 units on a scale
Standard Deviation 0.4
|
1.0 units on a scale
Standard Deviation 0.5
|
1.3 units on a scale
Standard Deviation 0.6
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
18-month assessment: 6 years and older
|
0.4 units on a scale
Standard Deviation 0.3
|
0.7 units on a scale
Standard Deviation 0.4
|
0.9 units on a scale
Standard Deviation 0.3
|
1.3 units on a scale
Standard Deviation 0.6
|
1.9 units on a scale
Standard Deviation 0.6
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
24-month assessment: under 6 years
|
0.4 units on a scale
Standard Deviation 0.3
|
0.7 units on a scale
Standard Deviation 0.4
|
0.8 units on a scale
Standard Deviation 0.5
|
1.0 units on a scale
Standard Deviation 0.6
|
1.4 units on a scale
Standard Deviation 0.7
|
|
Spinal Alignment and Range of Motion Measure (SAROMM)
24-month assessment: 6 years and older
|
0.4 units on a scale
Standard Deviation 0.3
|
0.6 units on a scale
Standard Deviation 0.4
|
0.9 units on a scale
Standard Deviation 0.5
|
1.3 units on a scale
Standard Deviation 0.6
|
2.0 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).
The FSA addresses force production ability in the neck and trunk flexor and extensor and bilateral hip and knee extensor and shoulder flexor muscle groups. Each muscle group is rated on a five-point ordinal scale from 1 = only flicker of contraction or just initiates movement against gravity to 5 = full available range against gravity and strong resistance. Scores are reported by calculating the average of scores across all 8 items. Scores range from 1 to 5. A higher score represents better force production ability.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Functional Strength Assessment (FSA)
Baseline: under 6 years
|
4.0 units on a scale
Standard Deviation 0.7
|
3.6 units on a scale
Standard Deviation 0.6
|
3.1 units on a scale
Standard Deviation 0.6
|
2.6 units on a scale
Standard Deviation 0.7
|
1.8 units on a scale
Standard Deviation 0.7
|
|
Functional Strength Assessment (FSA)
Baseline: 6 years and older
|
4.5 units on a scale
Standard Deviation 0.5
|
4.1 units on a scale
Standard Deviation 0.6
|
3.6 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 0.8
|
1.5 units on a scale
Standard Deviation 0.5
|
|
Functional Strength Assessment (FSA)
6-month assessment: under 6 years
|
4.0 units on a scale
Standard Deviation 0.7
|
3.6 units on a scale
Standard Deviation 0.6
|
3.1 units on a scale
Standard Deviation 0.6
|
2.7 units on a scale
Standard Deviation 0.6
|
1.7 units on a scale
Standard Deviation 0.6
|
|
Functional Strength Assessment (FSA)
6-month assessment: 6 years and older
|
4.5 units on a scale
Standard Deviation 0.5
|
4.1 units on a scale
Standard Deviation 0.6
|
3.6 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 0.8
|
1.6 units on a scale
Standard Deviation 0.6
|
|
Functional Strength Assessment (FSA)
12-month assessment: under 6 years
|
4.2 units on a scale
Standard Deviation 0.6
|
3.7 units on a scale
Standard Deviation 0.6
|
3.2 units on a scale
Standard Deviation 0.7
|
2.8 units on a scale
Standard Deviation 0.5
|
1.8 units on a scale
Standard Deviation 0.7
|
|
Functional Strength Assessment (FSA)
12-month assessment: 6 years and older
|
4.6 units on a scale
Standard Deviation 0.4
|
4.2 units on a scale
Standard Deviation 0.6
|
3.6 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 0.8
|
1.6 units on a scale
Standard Deviation 0.5
|
|
Functional Strength Assessment (FSA)
18-month assessment: under 6 years
|
4.0 units on a scale
Standard Deviation 0.7
|
3.5 units on a scale
Standard Deviation 0.7
|
3.1 units on a scale
Standard Deviation 0.7
|
2.9 units on a scale
Standard Deviation 0.6
|
1.7 units on a scale
Standard Deviation 0.6
|
|
Functional Strength Assessment (FSA)
18-month assessment: 6 years and older
|
4.5 units on a scale
Standard Deviation 0.5
|
4.1 units on a scale
Standard Deviation 0.7
|
3.7 units on a scale
Standard Deviation 0.7
|
2.8 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 0.5
|
|
Functional Strength Assessment (FSA)
24-month assessment: under 6 years
|
4.1 units on a scale
Standard Deviation 0.6
|
3.6 units on a scale
Standard Deviation 0.8
|
3.1 units on a scale
Standard Deviation 0.6
|
2.7 units on a scale
Standard Deviation 0.7
|
1.5 units on a scale
Standard Deviation 0.5
|
|
Functional Strength Assessment (FSA)
24-month assessment: 6 years and older
|
4.6 units on a scale
Standard Deviation 0.4
|
4.1 units on a scale
Standard Deviation 0.7
|
3.8 units on a scale
Standard Deviation 0.8
|
2.9 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The available N for 6MWT at 12M (highest #) is represented under Overall # Analyzed. For each time point, there are 2 rows for age. Of the available N at each time point (see Participant Flow), the Walk Test was given only to GMFCS Level I, II, or III age 3yrs+. The 1MWT was given to a smaller subset of children in the Physical Activity Sub-Study.
The 6MWT and 1MWT are submaximal, clinical exercise tests, in which the total distance traveled in 1-minute and 6-minutes, under controlled conditions, are measured. Within this study, the 6MWT/1MWT was conducted indoors or outdoors on a large, flat, hard terrain for children who were 3 years or older and who were walking without another person's assistance (GMFCS I, II, III). A surveyor's measure wheel was used to calculate the total distance (# of feet) walked and a stopwatch to keep track of the allocated time. Standardized directions are used to encourage the child to walk as far as possible in the time.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=201 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=144 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=63 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 18-month assessment: 6 years and older
|
242.18 Feet
Standard Deviation 57.16
|
208.03 Feet
Standard Deviation 44.36
|
103.38 Feet
Standard Deviation 49.29
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, Baseline: under 6 years
|
1080.3 Feet
Standard Deviation 273.6
|
697.3 Feet
Standard Deviation 347.1
|
396.2 Feet
Standard Deviation 317.6
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, Baseline: 6 years and older
|
1386.2 Feet
Standard Deviation 342.5
|
1041.8 Feet
Standard Deviation 303.4
|
616.9 Feet
Standard Deviation 307.0
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 6-month assessment: under 6 years
|
1012.8 Feet
Standard Deviation 301.6
|
611.1 Feet
Standard Deviation 314.5
|
359.5 Feet
Standard Deviation 273.8
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 6-month assessment: 6 years and older
|
1370.0 Feet
Standard Deviation 321.1
|
1075.0 Feet
Standard Deviation 322.1
|
574.0 Feet
Standard Deviation 312.9
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 12-month assessment: under 6 years
|
1026.7 Feet
Standard Deviation 282.7
|
658.9 Feet
Standard Deviation 339.4
|
314.6 Feet
Standard Deviation 237.1
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 12-month assessment: 6 years and older
|
1378.4 Feet
Standard Deviation 325.3
|
1047.7 Feet
Standard Deviation 356.5
|
690.7 Feet
Standard Deviation 261.1
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 18-month assessment: under 6 years
|
1020.1 Feet
Standard Deviation 311.5
|
601.6 Feet
Standard Deviation 239.0
|
331.6 Feet
Standard Deviation 218.2
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 18-month assessment: 6 years and older
|
1351.1 Feet
Standard Deviation 324.4
|
1109.0 Feet
Standard Deviation 324.2
|
636.5 Feet
Standard Deviation 312.9
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 24-month assessment: under 6 years
|
1197.6 Feet
Standard Deviation 1178.3
|
613.0 Feet
Standard Deviation 239.8
|
413.8 Feet
Standard Deviation 226.0
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
6MWT, 24-month assessment: 6 years and older
|
1401.7 Feet
Standard Deviation 288.6
|
1113.7 Feet
Standard Deviation 336.6
|
616.4 Feet
Standard Deviation 319.3
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, Baseline: under 6 years
|
—
|
118.93 Feet
Standard Deviation 79.28
|
15.30 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, Baseline: 6 years and older
|
263.18 Feet
Standard Deviation 49.23
|
120.13 Feet
Standard Deviation 74.74
|
78.42 Feet
Standard Deviation 13.31
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 6-month assessment: under 6 years
|
201.28 Feet
Standard Deviation 7.64
|
128.65 Feet
Standard Deviation 33.22
|
28.40 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 6-month assessment: 6 years and older
|
239.40 Feet
Standard Deviation 68.41
|
234.12 Feet
Standard Deviation 63.15
|
121.60 Feet
Standard Deviation 28.76
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 12-month assessment: under 6 years
|
215.37 Feet
Standard Deviation 28.96
|
150.58 Feet
Standard Deviation 56.83
|
70.95 Feet
Standard Deviation 4.60
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 12-month assessment: 6 years and older
|
242.51 Feet
Standard Deviation 66.46
|
211.11 Feet
Standard Deviation 67.26
|
102.62 Feet
Standard Deviation 32.93
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 18-month assessment: under 6 years
|
190.40 Feet
Standard Deviation 7.81
|
107.00 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
89.10 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 24-month assessment: under 6 years
|
194.00 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
77.40 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Six and One-minute Walk Test (6MWT, 1MWT)
1MWT, 24-month assessment: 6 years and older
|
254.34 Feet
Standard Deviation 56.63
|
239.30 Feet
Standard Deviation 157.77
|
84.34 Feet
Standard Deviation 44.86
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).
The EASE includes 4 activity-based items requiring parents to rate their children's levels of energy, the frequency and need for rest, and the average amount of time their children can engage in physical activity. Scoring for each item is on a Likert scale of 1-5 with the value of 1 = "Never" to 5 = "Always". The four questions include: 1) "my child's physical activity level is similar to other children his or her age," 2) "my child has a high physical energy level and rarely needs to take rests when moving himself or herself around during daily activities and play time," 3) "my child does enough activity so that he or she is breathing quickly or gets flushing in his or her face at least one time each day," and 4) "my child spends a lot of his or her play or free time doing activities that require lots of physical energy." Scores are reported by calculating the average across all 4 questions. Scores range from 1 to 5. A higher score represents better endurance for activity.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Early Activity Scale for Endurance (EASE)
Baseline: under 6 years
|
4.0 units on a scale
Standard Deviation 0.7
|
3.6 units on a scale
Standard Deviation 0.8
|
3.3 units on a scale
Standard Deviation 0.7
|
2.7 units on a scale
Standard Deviation 0.9
|
1.9 units on a scale
Standard Deviation 1.0
|
|
Early Activity Scale for Endurance (EASE)
Baseline: 6 years and older
|
3.7 units on a scale
Standard Deviation 0.7
|
3.2 units on a scale
Standard Deviation 0.8
|
3.0 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 0.9
|
1.7 units on a scale
Standard Deviation 0.7
|
|
Early Activity Scale for Endurance (EASE)
6-month assessment: under 6 years
|
4.0 units on a scale
Standard Deviation 0.7
|
3.6 units on a scale
Standard Deviation 0.8
|
3.3 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 0.9
|
1.9 units on a scale
Standard Deviation 0.9
|
|
Early Activity Scale for Endurance (EASE)
6-month assessment: 6 years and older
|
3.8 units on a scale
Standard Deviation 0.8
|
3.2 units on a scale
Standard Deviation 0.9
|
3.1 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 1.0
|
1.7 units on a scale
Standard Deviation 0.7
|
|
Early Activity Scale for Endurance (EASE)
12-month assessment: under 6 years
|
4.1 units on a scale
Standard Deviation 0.6
|
3.7 units on a scale
Standard Deviation 0.7
|
3.5 units on a scale
Standard Deviation 0.9
|
2.7 units on a scale
Standard Deviation 1.0
|
2.1 units on a scale
Standard Deviation 0.9
|
|
Early Activity Scale for Endurance (EASE)
12-month assessment: 6 years and older
|
3.8 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.9
|
3.2 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 0.9
|
1.7 units on a scale
Standard Deviation 0.7
|
|
Early Activity Scale for Endurance (EASE)
18-month assessment: under 6 years
|
4.3 units on a scale
Standard Deviation 0.7
|
3.7 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.8
|
2.6 units on a scale
Standard Deviation 0.9
|
1.7 units on a scale
Standard Deviation 0.7
|
|
Early Activity Scale for Endurance (EASE)
18-month assessment: 6 years and older
|
3.8 units on a scale
Standard Deviation 0.9
|
3.3 units on a scale
Standard Deviation 1.0
|
3.1 units on a scale
Standard Deviation 0.9
|
2.8 units on a scale
Standard Deviation 0.9
|
1.7 units on a scale
Standard Deviation 0.8
|
|
Early Activity Scale for Endurance (EASE)
24-month assessment: under 6 years
|
4.1 units on a scale
Standard Deviation 0.7
|
3.7 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.8
|
2.9 units on a scale
Standard Deviation 0.8
|
1.8 units on a scale
Standard Deviation 0.7
|
|
Early Activity Scale for Endurance (EASE)
24-month assessment: 6 years and older
|
3.9 units on a scale
Standard Deviation 0.8
|
3.3 units on a scale
Standard Deviation 0.9
|
3.1 units on a scale
Standard Deviation 0.9
|
2.7 units on a scale
Standard Deviation 0.9
|
1.8 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).
The Child Health Conditions questionnaire is a caregiver-completed measure of the extent to which health problems influence children's activities. Parents respond "yes" or "no" as to whether the child has each of the 16 health problems listed. If the child does not have a problem, a score of 0 is imputed for the next part of the question. If the child has a problem, parents are asked to judge the extent to which the problem affects the child's daily activities. This is measured using an 8-point ordinal scale from 0="does not have the problem", 1= "not at all" to 7 = "to a very great extent". Scores reported are the Child Health Conditions Impact average scores calculated by averaging across all 16 items. Scores range form 0 to 7. A higher score represents a greater impact of health conditions on daily activities.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Child Health Conditions Questionnaire
6-month assessment: 6 years and older
|
0.7 units on a scale
Standard Deviation 0.7
|
1.2 units on a scale
Standard Deviation 0.9
|
0.9 units on a scale
Standard Deviation 0.6
|
1.4 units on a scale
Standard Deviation 0.9
|
2.4 units on a scale
Standard Deviation 1.1
|
|
Child Health Conditions Questionnaire
12-month assessment: under 6 years
|
0.4 units on a scale
Standard Deviation 0.5
|
0.7 units on a scale
Standard Deviation 0.6
|
0.8 units on a scale
Standard Deviation 0.7
|
1.3 units on a scale
Standard Deviation 0.9
|
2.2 units on a scale
Standard Deviation 0.9
|
|
Child Health Conditions Questionnaire
12-month assessment: 6 years and older
|
0.7 units on a scale
Standard Deviation 0.7
|
1.0 units on a scale
Standard Deviation 0.9
|
0.8 units on a scale
Standard Deviation 0.6
|
1.5 units on a scale
Standard Deviation 0.9
|
2.3 units on a scale
Standard Deviation 1.1
|
|
Child Health Conditions Questionnaire
18-month assessment: under 6 years
|
0.5 units on a scale
Standard Deviation 0.6
|
0.9 units on a scale
Standard Deviation 0.8
|
1.0 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 0.9
|
2.2 units on a scale
Standard Deviation 0.8
|
|
Child Health Conditions Questionnaire
18-month assessment: 6 years and older
|
0.7 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 0.8
|
0.9 units on a scale
Standard Deviation 0.7
|
1.3 units on a scale
Standard Deviation 0.8
|
2.3 units on a scale
Standard Deviation 1.0
|
|
Child Health Conditions Questionnaire
24-month assessment: under 6 years
|
0.6 units on a scale
Standard Deviation 0.8
|
0.8 units on a scale
Standard Deviation 0.6
|
0.8 units on a scale
Standard Deviation 0.6
|
1.2 units on a scale
Standard Deviation 1.0
|
2.4 units on a scale
Standard Deviation 1.1
|
|
Child Health Conditions Questionnaire
24-month assessment: 6 years and older
|
0.6 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 0.9
|
0.8 units on a scale
Standard Deviation 0.7
|
1.4 units on a scale
Standard Deviation 0.9
|
2.4 units on a scale
Standard Deviation 1.0
|
|
Child Health Conditions Questionnaire
Baseline: under 6 years
|
0.5 units on a scale
Standard Deviation 0.6
|
0.9 units on a scale
Standard Deviation 0.7
|
0.9 units on a scale
Standard Deviation 0.7
|
1.4 units on a scale
Standard Deviation 0.8
|
2.1 units on a scale
Standard Deviation 1.0
|
|
Child Health Conditions Questionnaire
Baseline: 6 years and older
|
0.7 units on a scale
Standard Deviation 0.6
|
1.1 units on a scale
Standard Deviation 0.9
|
0.9 units on a scale
Standard Deviation 0.6
|
1.5 units on a scale
Standard Deviation 1.0
|
2.4 units on a scale
Standard Deviation 1.1
|
|
Child Health Conditions Questionnaire
6-month assessment: under 6 years
|
0.5 units on a scale
Standard Deviation 0.6
|
0.8 units on a scale
Standard Deviation 0.6
|
0.9 units on a scale
Standard Deviation 0.7
|
1.3 units on a scale
Standard Deviation 0.9
|
2.2 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).
CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 1 captures participation of the child in family/community and leisure/recreational activities. Part 1 is scored on two 5-point Likert scales: 1) how often a child participates (1=almost never to 4=very often), and 2) the degree of enjoyment (1=not at all to 5 a great deal). A Rasch analysis has converted scores into 0-100 scaled scores. A higher score represents a higher degree of 'leisure.'
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, Baseline: <6yrs
|
67.0 units on a scale
Standard Deviation 13.4
|
65.1 units on a scale
Standard Deviation 12.4
|
62.3 units on a scale
Standard Deviation 12.6
|
55.8 units on a scale
Standard Deviation 10.5
|
54.0 units on a scale
Standard Deviation 12.5
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, Baseline 6yrs+
|
70.2 units on a scale
Standard Deviation 15.4
|
63.9 units on a scale
Standard Deviation 12.7
|
62.6 units on a scale
Standard Deviation 10.9
|
58.9 units on a scale
Standard Deviation 12.9
|
52.4 units on a scale
Standard Deviation 9.7
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 6-month assessment:<6yrs
|
67.9 units on a scale
Standard Deviation 13.6
|
67.7 units on a scale
Standard Deviation 12.6
|
57.8 units on a scale
Standard Deviation 8.8
|
57.3 units on a scale
Standard Deviation 9.3
|
53.9 units on a scale
Standard Deviation 17.1
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 6-month assessment 6yrs+
|
70.0 units on a scale
Standard Deviation 15.5
|
61.4 units on a scale
Standard Deviation 12.9
|
63.0 units on a scale
Standard Deviation 12.6
|
60.2 units on a scale
Standard Deviation 12.4
|
50.0 units on a scale
Standard Deviation 9.8
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 12-month assessment: <6yrs
|
70.3 units on a scale
Standard Deviation 13.3
|
64.2 units on a scale
Standard Deviation 12.6
|
62.3 units on a scale
Standard Deviation 9.7
|
56.1 units on a scale
Standard Deviation 9.9
|
52.1 units on a scale
Standard Deviation 9.8
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 12-month assessment: 6yrs+
|
70.3 units on a scale
Standard Deviation 14.1
|
64.1 units on a scale
Standard Deviation 13.1
|
62.1 units on a scale
Standard Deviation 12.5
|
58.1 units on a scale
Standard Deviation 10.8
|
50.5 units on a scale
Standard Deviation 9.9
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 18-month assessment: <6yrs
|
69.7 units on a scale
Standard Deviation 12.5
|
66.5 units on a scale
Standard Deviation 14.2
|
65.4 units on a scale
Standard Deviation 10.5
|
58.6 units on a scale
Standard Deviation 10.2
|
54.0 units on a scale
Standard Deviation 14.1
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 18-month assessment 6yrs+
|
69.3 units on a scale
Standard Deviation 13.7
|
64.8 units on a scale
Standard Deviation 14.2
|
58.3 units on a scale
Standard Deviation 9.2
|
58.0 units on a scale
Standard Deviation 11.2
|
48.4 units on a scale
Standard Deviation 11.2
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 24-month assessment: <6yrs
|
71.1 units on a scale
Standard Deviation 16.2
|
70.7 units on a scale
Standard Deviation 14.6
|
67.1 units on a scale
Standard Deviation 14.2
|
56.6 units on a scale
Standard Deviation 9.5
|
51.8 units on a scale
Standard Deviation 14.0
|
|
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Participation, 24-month assessment: 6yrs+
|
70.4 units on a scale
Standard Deviation 15.3
|
65.5 units on a scale
Standard Deviation 13.6
|
60.2 units on a scale
Standard Deviation 12.0
|
56.3 units on a scale
Standard Deviation 10.1
|
48.5 units on a scale
Standard Deviation 13.7
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).
CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 2 measures self-care, defined as the degree that the child participates in daily feeding, dressing, bathing, and toileting. Part 2 is scored on a 5-point Likert scale from 1= 'does not do the activity' to 5= 'does the activity independently most of the time'. The scale distinguishes the need for physical assistance from a person, the ability to complete the activity under various conditions, and the amount of the activity able to complete. A Rasch analysis has converted scores into 0-100 scaled scores for both parts. A higher score represents a higher degree of self-care (Part 2) participation.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, Baseline: <6yrs
|
54.4 units on a scale
Standard Deviation 12.5
|
49.0 units on a scale
Standard Deviation 9.7
|
44.4 units on a scale
Standard Deviation 10.0
|
33.6 units on a scale
Standard Deviation 14.6
|
16.1 units on a scale
Standard Deviation 12.3
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, Baseline: 6yrs+
|
73.0 units on a scale
Standard Deviation 14.4
|
62.1 units on a scale
Standard Deviation 13.5
|
55.3 units on a scale
Standard Deviation 9.3
|
35.8 units on a scale
Standard Deviation 15.5
|
13.6 units on a scale
Standard Deviation 15.1
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 6-month assessment: <6yrs
|
56.3 units on a scale
Standard Deviation 11.4
|
50.6 units on a scale
Standard Deviation 8.8
|
44.0 units on a scale
Standard Deviation 8.8
|
34.0 units on a scale
Standard Deviation 14.5
|
15.6 units on a scale
Standard Deviation 13.6
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 6-month assessment: 6yrs+
|
72.1 units on a scale
Standard Deviation 12.7
|
63.7 units on a scale
Standard Deviation 15.8
|
56.0 units on a scale
Standard Deviation 10.9
|
37.6 units on a scale
Standard Deviation 16.1
|
12.1 units on a scale
Standard Deviation 14.8
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 12-month assessment: <6yrs
|
61.8 units on a scale
Standard Deviation 12.7
|
54.0 units on a scale
Standard Deviation 10.5
|
47.1 units on a scale
Standard Deviation 8.2
|
37.3 units on a scale
Standard Deviation 11.8
|
16.5 units on a scale
Standard Deviation 13.4
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 12-month assessment: 6yrs+
|
76.3 units on a scale
Standard Deviation 14.8
|
64.5 units on a scale
Standard Deviation 14.9
|
59.2 units on a scale
Standard Deviation 13.4
|
36.9 units on a scale
Standard Deviation 17.6
|
13.1 units on a scale
Standard Deviation 16.1
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 18-month assessment: <6yrs
|
61.4 units on a scale
Standard Deviation 14.0
|
50.7 units on a scale
Standard Deviation 12.6
|
46.7 units on a scale
Standard Deviation 7.2
|
38.0 units on a scale
Standard Deviation 14.4
|
18.1 units on a scale
Standard Deviation 13.6
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 18-month assessment: 6yrs+
|
75.2 units on a scale
Standard Deviation 15.1
|
65.9 units on a scale
Standard Deviation 16.8
|
59.3 units on a scale
Standard Deviation 13.1
|
37.1 units on a scale
Standard Deviation 18.2
|
13.6 units on a scale
Standard Deviation 15.4
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 24-month assessment: <6yrs
|
62.3 units on a scale
Standard Deviation 12.8
|
53.5 units on a scale
Standard Deviation 9.7
|
48.3 units on a scale
Standard Deviation 6.7
|
34.6 units on a scale
Standard Deviation 16.8
|
15.9 units on a scale
Standard Deviation 13.8
|
|
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
Self-care, 24-month assessment: 6yrs+
|
76.8 units on a scale
Standard Deviation 14.4
|
66.1 units on a scale
Standard Deviation 16.5
|
61.1 units on a scale
Standard Deviation 15.0
|
37.5 units on a scale
Standard Deviation 16.3
|
11.6 units on a scale
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: up to 24-monthsPopulation: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow.
The Services questionnaire is a caregiver-completed measure of the medical and rehabilitation services provided to the child in the period since the last data collection point. The variables used for the analysis of the relationship between services and four outcomes are reported. These data are: mean amount of physical, occupational, and speech and language therapy service sessions per year (recorded in 5 ordinal intensity times/year categories: 1=0-1, 2=2-30, 3=31-52, 4=53-155, 5=\>156), mean family centeredness across 14 items (scored in 5 ordinal categories: 1=not at all, 2=small, 3=moderate, 4=great, 5=very great extent), mean rating of parents' perceptions that services were meeting their children's needs (scored on ordinal scale 1=not at all, 2=small, 3=moderate, 4=great extent, 5=completely), mean rating of the extent to which therapy was focused into 8 categories (scored in same ordinal categories as family centeredness above). Higher scores indicate a great amount or extent.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Services Questionnaire
Intensity of services: PT Baseline
|
2.2 units on a scale
Standard Deviation 0.8
|
2.5 units on a scale
Standard Deviation 1.0
|
2.8 units on a scale
Standard Deviation 0.9
|
2.9 units on a scale
Standard Deviation 1.0
|
2.9 units on a scale
Standard Deviation 1.0
|
|
Services Questionnaire
Focus of therapy, assistive devices: 18M
|
2.7 units on a scale
Standard Deviation 1.6
|
3.3 units on a scale
Standard Deviation 1.5
|
3.4 units on a scale
Standard Deviation 1.5
|
3.7 units on a scale
Standard Deviation 1.2
|
3.5 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Intensity of services: PT 6M
|
2.2 units on a scale
Standard Deviation 0.9
|
2.8 units on a scale
Standard Deviation 1.0
|
3.3 units on a scale
Standard Deviation 1.0
|
3.2 units on a scale
Standard Deviation 1.0
|
3.2 units on a scale
Standard Deviation 1.0
|
|
Services Questionnaire
Intensity of services: PT 12M
|
2.0 units on a scale
Standard Deviation 0.9
|
2.6 units on a scale
Standard Deviation 1.1
|
3.0 units on a scale
Standard Deviation 1.0
|
3.0 units on a scale
Standard Deviation 1.0
|
2.9 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: PT 18M
|
2.1 units on a scale
Standard Deviation 1.1
|
2.7 units on a scale
Standard Deviation 1.2
|
3.0 units on a scale
Standard Deviation 1.1
|
3.2 units on a scale
Standard Deviation 1.0
|
3.1 units on a scale
Standard Deviation 1.0
|
|
Services Questionnaire
Intensity of services: PT 24M
|
2.0 units on a scale
Standard Deviation 1.0
|
2.8 units on a scale
Standard Deviation 1.1
|
3.0 units on a scale
Standard Deviation 1.1
|
3.3 units on a scale
Standard Deviation 1.0
|
3.0 units on a scale
Standard Deviation 1.0
|
|
Services Questionnaire
Intensity of services: OT Baseline
|
2.0 units on a scale
Standard Deviation 0.8
|
2.2 units on a scale
Standard Deviation 0.9
|
2.3 units on a scale
Standard Deviation 0.9
|
2.6 units on a scale
Standard Deviation 0.8
|
2.6 units on a scale
Standard Deviation 1.0
|
|
Services Questionnaire
Intensity of services: OT 6M
|
2.1 units on a scale
Standard Deviation 0.9
|
2.5 units on a scale
Standard Deviation 1.0
|
2.6 units on a scale
Standard Deviation 1.1
|
2.8 units on a scale
Standard Deviation 1.0
|
2.8 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: OT 12M
|
2.0 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 1.0
|
2.5 units on a scale
Standard Deviation 1.1
|
2.6 units on a scale
Standard Deviation 0.9
|
2.5 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: OT 18M
|
2.1 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.0
|
2.5 units on a scale
Standard Deviation 1.1
|
2.9 units on a scale
Standard Deviation 1.0
|
2.6 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: OT 24M
|
2.0 units on a scale
Standard Deviation 1.0
|
2.3 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.1
|
2.9 units on a scale
Standard Deviation 1.0
|
2.5 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: ST: baseline
|
1.7 units on a scale
Standard Deviation 0.9
|
1.9 units on a scale
Standard Deviation 1.0
|
2.0 units on a scale
Standard Deviation 1.0
|
2.3 units on a scale
Standard Deviation 1.0
|
2.4 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: ST: 6M
|
1.8 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.2
|
2.6 units on a scale
Standard Deviation 1.2
|
2.6 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: ST: 12M
|
1.7 units on a scale
Standard Deviation 1.0
|
2.0 units on a scale
Standard Deviation 1.2
|
1.9 units on a scale
Standard Deviation 1.1
|
2.5 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Intensity of services: ST: 18M
|
1.8 units on a scale
Standard Deviation 1.1
|
2.1 units on a scale
Standard Deviation 1.2
|
2.2 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Intensity of services: ST: 24M
|
1.7 units on a scale
Standard Deviation 1.1
|
2.0 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.1
|
2.6 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Family centeredness: Baseline
|
3.5 units on a scale
Standard Deviation 0.9
|
3.5 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.7
|
3.6 units on a scale
Standard Deviation 0.7
|
3.5 units on a scale
Standard Deviation 0.8
|
|
Services Questionnaire
Family centeredness: 6M
|
3.4 units on a scale
Standard Deviation 0.9
|
3.3 units on a scale
Standard Deviation 0.9
|
3.5 units on a scale
Standard Deviation 0.7
|
3.5 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.9
|
|
Services Questionnaire
Family centeredness: 12M
|
3.4 units on a scale
Standard Deviation 0.9
|
3.4 units on a scale
Standard Deviation 0.9
|
3.4 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.8
|
|
Services Questionnaire
Family centeredness: 18M
|
3.2 units on a scale
Standard Deviation 0.9
|
3.2 units on a scale
Standard Deviation 0.9
|
3.3 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.9
|
3.2 units on a scale
Standard Deviation 0.8
|
|
Services Questionnaire
Family centeredness: 24M
|
3.2 units on a scale
Standard Deviation 0.9
|
3.3 units on a scale
Standard Deviation 0.9
|
3.3 units on a scale
Standard Deviation 0.9
|
3.4 units on a scale
Standard Deviation 0.9
|
3.3 units on a scale
Standard Deviation 0.9
|
|
Services Questionnaire
Services meeting needs AVG: Baseline
|
3.7 units on a scale
Standard Deviation 0.8
|
3.7 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.7
|
3.4 units on a scale
Standard Deviation 0.7
|
3.3 units on a scale
Standard Deviation 0.8
|
|
Services Questionnaire
Services meeting needs AVG: 6M
|
3.8 units on a scale
Standard Deviation 0.9
|
3.7 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.8
|
3.3 units on a scale
Standard Deviation 0.7
|
|
Services Questionnaire
Services meeting needs AVG: 12M
|
3.8 units on a scale
Standard Deviation 1.0
|
3.6 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.7
|
3.3 units on a scale
Standard Deviation 0.8
|
|
Services Questionnaire
Services meeting needs AVG: 18M
|
3.7 units on a scale
Standard Deviation 1.0
|
3.5 units on a scale
Standard Deviation 0.9
|
3.4 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.8
|
3.1 units on a scale
Standard Deviation 0.8
|
|
Services Questionnaire
Services meeting needs AVG: 24M
|
3.8 units on a scale
Standard Deviation 0.9
|
3.5 units on a scale
Standard Deviation 0.9
|
3.5 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.8
|
3.1 units on a scale
Standard Deviation 0.8
|
|
Services Questionnaire
Focus of therapy, stretching muscles: Baseline
|
3.8 units on a scale
Standard Deviation 1.2
|
4.0 units on a scale
Standard Deviation 1.2
|
4.0 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
4.1 units on a scale
Standard Deviation 1.0
|
|
Services Questionnaire
Focus of therapy, stretching muscles: 6M
|
3.7 units on a scale
Standard Deviation 1.3
|
4.0 units on a scale
Standard Deviation 1.2
|
4.1 units on a scale
Standard Deviation 1.0
|
3.9 units on a scale
Standard Deviation 1.2
|
4.1 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, stretching muscles: 12M
|
3.8 units on a scale
Standard Deviation 1.3
|
4.0 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
3.9 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, stretching muscles: 18M
|
3.7 units on a scale
Standard Deviation 1.4
|
4.1 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.2
|
4.0 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Focus of therapy, stretching muscles: 24M
|
3.8 units on a scale
Standard Deviation 1.3
|
4.0 units on a scale
Standard Deviation 1.2
|
3.9 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
3.9 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, activities to improve: Baseline
|
3.5 units on a scale
Standard Deviation 1.5
|
4.0 units on a scale
Standard Deviation 1.2
|
4.2 units on a scale
Standard Deviation 1.0
|
3.9 units on a scale
Standard Deviation 1.1
|
3.5 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, activities to improve: 6M
|
3.6 units on a scale
Standard Deviation 1.4
|
3.8 units on a scale
Standard Deviation 1.4
|
4.2 units on a scale
Standard Deviation 1.0
|
3.9 units on a scale
Standard Deviation 1.2
|
3.4 units on a scale
Standard Deviation 1.5
|
|
Services Questionnaire
Focus of therapy, activities to improve: 12M
|
3.4 units on a scale
Standard Deviation 1.5
|
3.8 units on a scale
Standard Deviation 1.4
|
4.2 units on a scale
Standard Deviation 1.0
|
4.0 units on a scale
Standard Deviation 1.0
|
3.3 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, activities to improve: 18M
|
3.5 units on a scale
Standard Deviation 1.5
|
3.9 units on a scale
Standard Deviation 1.2
|
4.0 units on a scale
Standard Deviation 1.2
|
3.9 units on a scale
Standard Deviation 1.1
|
3.1 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, activities to improve: 24M
|
3.5 units on a scale
Standard Deviation 1.5
|
3.7 units on a scale
Standard Deviation 1.4
|
4.0 units on a scale
Standard Deviation 1.1
|
3.8 units on a scale
Standard Deviation 1.2
|
3.2 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, health/well-being: Baseline
|
3.0 units on a scale
Standard Deviation 1.4
|
3.2 units on a scale
Standard Deviation 1.3
|
3.1 units on a scale
Standard Deviation 1.2
|
3.2 units on a scale
Standard Deviation 1.3
|
2.9 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, health/well-being: 6M
|
3.1 units on a scale
Standard Deviation 1.5
|
3.1 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 1.4
|
3.0 units on a scale
Standard Deviation 1.3
|
3.0 units on a scale
Standard Deviation 1.5
|
|
Services Questionnaire
Focus of therapy, health/well-being: 12M
|
2.9 units on a scale
Standard Deviation 1.4
|
3.0 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 1.3
|
3.1 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, health/well-being: 18M
|
2.8 units on a scale
Standard Deviation 1.5
|
3.0 units on a scale
Standard Deviation 1.4
|
2.9 units on a scale
Standard Deviation 1.3
|
3.1 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, health/well-being: 24M
|
2.9 units on a scale
Standard Deviation 1.5
|
3.0 units on a scale
Standard Deviation 1.5
|
2.9 units on a scale
Standard Deviation 1.3
|
2.9 units on a scale
Standard Deviation 1.4
|
2.7 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, self-awareness: Baseline
|
3.2 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, self-awareness: 6M
|
3.3 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.2
|
3.0 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, self-awareness: 12M
|
3.0 units on a scale
Standard Deviation 1.4
|
3.3 units on a scale
Standard Deviation 1.4
|
3.3 units on a scale
Standard Deviation 1.3
|
3.2 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, self-awareness: 18M
|
3.2 units on a scale
Standard Deviation 1.5
|
3.2 units on a scale
Standard Deviation 1.4
|
3.0 units on a scale
Standard Deviation 1.3
|
3.2 units on a scale
Standard Deviation 1.4
|
2.6 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, self-awareness: 24M
|
3.1 units on a scale
Standard Deviation 1.5
|
3.2 units on a scale
Standard Deviation 1.5
|
3.4 units on a scale
Standard Deviation 1.3
|
3.1 units on a scale
Standard Deviation 1.3
|
2.7 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, relaxation: Baseline
|
3.3 units on a scale
Standard Deviation 1.4
|
3.5 units on a scale
Standard Deviation 1.3
|
3.8 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Focus of therapy, relaxation: 6M
|
3.4 units on a scale
Standard Deviation 1.5
|
3.7 units on a scale
Standard Deviation 1.2
|
4.1 units on a scale
Standard Deviation 1.0
|
3.9 units on a scale
Standard Deviation 1.1
|
4.1 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Focus of therapy, relaxation: 12M
|
3.3 units on a scale
Standard Deviation 1.4
|
3.7 units on a scale
Standard Deviation 1.3
|
3.7 units on a scale
Standard Deviation 1.2
|
3.8 units on a scale
Standard Deviation 1.2
|
3.9 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Focus of therapy, relaxation: 18M
|
3.4 units on a scale
Standard Deviation 1.4
|
3.7 units on a scale
Standard Deviation 1.3
|
3.6 units on a scale
Standard Deviation 1.4
|
3.9 units on a scale
Standard Deviation 1.1
|
3.9 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Focus of therapy, relaxation: 24M
|
3.3 units on a scale
Standard Deviation 1.5
|
3.5 units on a scale
Standard Deviation 1.4
|
3.5 units on a scale
Standard Deviation 1.1
|
3.8 units on a scale
Standard Deviation 1.2
|
3.8 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, self-care routines: Baseline
|
2.1 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.3
|
2.7 units on a scale
Standard Deviation 1.2
|
2.5 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.4
|
|
Services Questionnaire
Focus of therapy, self-care routines: 6M
|
2.4 units on a scale
Standard Deviation 1.4
|
2.7 units on a scale
Standard Deviation 1.5
|
2.6 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.1
|
2.0 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, self-care routines: 12M
|
2.2 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.4
|
2.9 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, self-care routines: 18M
|
2.5 units on a scale
Standard Deviation 1.5
|
2.5 units on a scale
Standard Deviation 1.4
|
2.6 units on a scale
Standard Deviation 1.4
|
2.4 units on a scale
Standard Deviation 1.2
|
1.8 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Focus of therapy, self-care routines: 24M
|
2.3 units on a scale
Standard Deviation 1.4
|
2.3 units on a scale
Standard Deviation 1.4
|
2.7 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, assistive devices: Baseline
|
2.6 units on a scale
Standard Deviation 1.5
|
3.1 units on a scale
Standard Deviation 1.4
|
3.6 units on a scale
Standard Deviation 1.1
|
3.8 units on a scale
Standard Deviation 1.1
|
3.7 units on a scale
Standard Deviation 1.1
|
|
Services Questionnaire
Focus of therapy, assistive devices: 6M
|
2.6 units on a scale
Standard Deviation 1.6
|
3.1 units on a scale
Standard Deviation 1.5
|
3.3 units on a scale
Standard Deviation 1.3
|
3.7 units on a scale
Standard Deviation 1.2
|
3.8 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, assistive devices: 12M
|
2.4 units on a scale
Standard Deviation 1.5
|
3.5 units on a scale
Standard Deviation 1.4
|
3.6 units on a scale
Standard Deviation 1.2
|
3.8 units on a scale
Standard Deviation 1.1
|
3.5 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, assistive devices: 24M
|
2.4 units on a scale
Standard Deviation 1.5
|
2.8 units on a scale
Standard Deviation 1.6
|
3.4 units on a scale
Standard Deviation 1.3
|
3.6 units on a scale
Standard Deviation 1.2
|
3.6 units on a scale
Standard Deviation 1.3
|
|
Services Questionnaire
Focus of therapy, structured play: Baseline
|
3.0 units on a scale
Standard Deviation 1.5
|
3.2 units on a scale
Standard Deviation 1.3
|
3.5 units on a scale
Standard Deviation 1.2
|
3.4 units on a scale
Standard Deviation 1.2
|
3.2 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, structured play: 6M
|
3.1 units on a scale
Standard Deviation 1.5
|
3.4 units on a scale
Standard Deviation 1.3
|
3.6 units on a scale
Standard Deviation 1.2
|
3.4 units on a scale
Standard Deviation 1.2
|
3.2 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, structured play: 12M
|
2.7 units on a scale
Standard Deviation 1.5
|
3.1 units on a scale
Standard Deviation 1.5
|
3.3 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 1.1
|
3.1 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, structured play: 18M
|
3.0 units on a scale
Standard Deviation 1.5
|
3.1 units on a scale
Standard Deviation 1.4
|
3.2 units on a scale
Standard Deviation 1.4
|
3.4 units on a scale
Standard Deviation 1.1
|
3.0 units on a scale
Standard Deviation 1.2
|
|
Services Questionnaire
Focus of therapy, structured play: 24M
|
2.8 units on a scale
Standard Deviation 1.5
|
2.8 units on a scale
Standard Deviation 1.5
|
3.0 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: BaselineThe GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations; II: Walks with limitations; III: Walks using a hand-held mobility device; IV: Self-mobility with limitations; may use powered mobility; and V: Transported in manual wheelchair. Descriptors for the five levels vary by age of the child. Children were classified by consensus between parents and assessing therapists by comparing the child's functional movement ability to descriptors for each level of classification.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=708 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)
GMFCS Level I
|
32.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)
GMFCS Level II
|
22.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)
GMFCS Level III
|
11.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)
GMFCS Level IV
|
18.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)
GMFCS Level V
|
15.7 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)Population: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)
The MACS is a classification system based on functional hand movement ability. MACS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Handles objects easily \& effectively; II: Handles most objects with somewhat reduced quality and/or speed; III: Handles objects with difficulty, needs help to prepare and/or modify activities; IV: Handles a limited selection of easily managed objects; and V: Does not handle objects and has severely limited ability to perform even simple actions.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Manual Ability Classification System (MACS)
MACS Level I
|
95 participants
|
33 participants
|
12 participants
|
4 participants
|
0 participants
|
|
Manual Ability Classification System (MACS)
MACS Level II
|
121 participants
|
96 participants
|
40 participants
|
21 participants
|
2 participants
|
|
Manual Ability Classification System (MACS)
MACS Level III
|
9 participants
|
24 participants
|
21 participants
|
49 participants
|
4 participants
|
|
Manual Ability Classification System (MACS)
MACS Level IV
|
2 participants
|
8 participants
|
6 participants
|
49 participants
|
52 participants
|
|
Manual Ability Classification System (MACS)
MACS Level V
|
0 participants
|
0 participants
|
1 participants
|
6 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)Population: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)
The CFCS is a classification system based on functional communication ability. CFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Effective sender/receiver with familiar/unfamiliar partners; II: Effective but slower paced sender and/or receiver with familiar/unfamiliar partners; III: Effective sender \& receiver with familiar partners; IV: Inconsistent sender and/or receiver with familiar partners; and V: Seldom effective sender \& receiver with familiar partners.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=227 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=161 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=80 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=129 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=111 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Communication Function Classification System (CFCS)
CFCS Level I
|
144 participants
|
63 participants
|
34 participants
|
20 participants
|
3 participants
|
|
Communication Function Classification System (CFCS)
CFCS Level II
|
46 participants
|
46 participants
|
17 participants
|
16 participants
|
1 participants
|
|
Communication Function Classification System (CFCS)
CFCS Level III
|
26 participants
|
28 participants
|
18 participants
|
38 participants
|
24 participants
|
|
Communication Function Classification System (CFCS)
CFCS Level IV
|
10 participants
|
23 participants
|
9 participants
|
45 participants
|
42 participants
|
|
Communication Function Classification System (CFCS)
CFCS Level V
|
1 participants
|
1 participants
|
2 participants
|
10 participants
|
41 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24-monthsPopulation: StepWatch data was collected on a subset of 50 children in GMFCS Level I, II or II who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).
For participants who were ambulatory (GMFCS levels I, II, III), walking activity performance was measured within the context of daily life with a monitor called the StepWatch. It is a small (70 x 50 x 20 mm; 38 g), waterproof, self-contained device that is worn on the left ankle. Participants wore the StepWatch on their ankle (inside a knit cuff) each day for a seven-day sample. Specific variables reported are an intensity measure, average number of strides per day faster than 30 per minute (moderate to high intensity strides) for the seven-day sample.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=23 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=20 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=7 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: baseline <6yrs
|
1523.0 Strides per day faster than 30 /minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
1185.0 Strides per day faster than 30 /minute
Standard Deviation 401.1
|
42.0 Strides per day faster than 30 /minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: baseline 6yrs +
|
2930.2 Strides per day faster than 30 /minute
Standard Deviation 306.6
|
1691.3 Strides per day faster than 30 /minute
Standard Deviation 489.1
|
525.0 Strides per day faster than 30 /minute
Standard Deviation 125.8
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 6M <6yrs
|
1870.6 Strides per day faster than 30 /minute
Standard Deviation 907.3
|
1641.5 Strides per day faster than 30 /minute
Standard Deviation 711.8
|
0.0 Strides per day faster than 30 /minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 6M 6yrs +
|
2242.6 Strides per day faster than 30 /minute
Standard Deviation 1683.2
|
1892.9 Strides per day faster than 30 /minute
Standard Deviation 827.5
|
947.5 Strides per day faster than 30 /minute
Standard Deviation 481.1
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 12M <6yrs
|
2674.9 Strides per day faster than 30 /minute
Standard Deviation 1403.5
|
1262.0 Strides per day faster than 30 /minute
Standard Deviation 425.0
|
249.0 Strides per day faster than 30 /minute
Standard Deviation 321.0
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 12M 6yrs +
|
2080.6 Strides per day faster than 30 /minute
Standard Deviation 923.7
|
1650.6 Strides per day faster than 30 /minute
Standard Deviation 801.6
|
721.1 Strides per day faster than 30 /minute
Standard Deviation 515.4
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 18M <6yrs
|
3530.3 Strides per day faster than 30 /minute
Standard Deviation 1128.6
|
1084.1 Strides per day faster than 30 /minute
Standard Deviation 593.8
|
673.0 Strides per day faster than 30 /minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 18M 6yrs +
|
2297.6 Strides per day faster than 30 /minute
Standard Deviation 822.7
|
1662.2 Strides per day faster than 30 /minute
Standard Deviation 725.0
|
429.9 Strides per day faster than 30 /minute
Standard Deviation 411.6
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 24M <6yrs
|
3066.0 Strides per day faster than 30 /minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
653.9 Strides per day faster than 30 /minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
1706.0 Strides per day faster than 30 /minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
StepWatch AVG strides/day >30/min: 24M 6yrs +
|
2766.8 Strides per day faster than 30 /minute
Standard Deviation 1054.7
|
1722.3 Strides per day faster than 30 /minute
Standard Deviation 862.6
|
587.4 Strides per day faster than 30 /minute
Standard Deviation 669.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24-monthsPopulation: StepWatch data was collected on a subset of 50 children in GMFCS Level I, II or II who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).
For participants who were ambulatory (GMFCS levels I, II, III), walking activity performance was measured within the context of daily life with a monitor called the StepWatch. It is a small (70 x 50 x 20 mm; 38 g), waterproof, self-contained device that is worn on the left ankle. Participants wore the StepWatch on their ankle (inside a knit cuff) each day for a seven-day sample. Specific variables reported are an an amount measure, average number of single leg strides per day for the seven-day sample.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=23 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=20 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=7 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: baseline <6yrs
|
4674.0 Avg number single leg strides per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
3622.7 Avg number single leg strides per day
Standard Deviation 899.8
|
753.0 Avg number single leg strides per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: baseline 6yrs +
|
6548.2 Avg number single leg strides per day
Standard Deviation 724.3
|
4196.7 Avg number single leg strides per day
Standard Deviation 788.8
|
2173.3 Avg number single leg strides per day
Standard Deviation 501.1
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 6M <6yrs
|
5031.7 Avg number single leg strides per day
Standard Deviation 1720.0
|
3851.0 Avg number single leg strides per day
Standard Deviation 751.8
|
140.0 Avg number single leg strides per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 6M 6yrs +
|
5161.3 Avg number single leg strides per day
Standard Deviation 2476.7
|
4733.5 Avg number single leg strides per day
Standard Deviation 1445.4
|
2761.5 Avg number single leg strides per day
Standard Deviation 851.5
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 12M <6yrs
|
6441.9 Avg number single leg strides per day
Standard Deviation 2438.9
|
3669.1 Avg number single leg strides per day
Standard Deviation 805.8
|
1829.5 Avg number single leg strides per day
Standard Deviation 1883.0
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 12M 6yrs +
|
5190.7 Avg number single leg strides per day
Standard Deviation 1569.7
|
4329.3 Avg number single leg strides per day
Standard Deviation 1550.3
|
2144.2 Avg number single leg strides per day
Standard Deviation 1172.2
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 18M <6yrs
|
7205.3 Avg number single leg strides per day
Standard Deviation 1387.3
|
3441.9 Avg number single leg strides per day
Standard Deviation 1291.4
|
4083.0 Avg number single leg strides per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 18M 6yrs +
|
5381.5 Avg number single leg strides per day
Standard Deviation 1429.6
|
4116.6 Avg number single leg strides per day
Standard Deviation 1023.0
|
1751.3 Avg number single leg strides per day
Standard Deviation 1308.9
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 24M <6yrs
|
5956.0 Avg number single leg strides per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
2671.5 Avg number single leg strides per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
5559.0 Avg number single leg strides per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
StepWatch AVG SL strides/day: 24M 6yrs +
|
6096.0 Avg number single leg strides per day
Standard Deviation 1394.0
|
4014.7 Avg number single leg strides per day
Standard Deviation 1507.4
|
1869.7 Avg number single leg strides per day
Standard Deviation 1522.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24-monthsPopulation: Actigraph data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).
Participants wore a 3-dimensional accelerometer (Actigraph wGT3X) on their dominant wrist for a seven-day sample. Specific variables reported are number of minutes time spent in moderate/vigorous physical activity for a seven-day sample. The wrist mounted Actigraph counts were converted to waist worn activity counts.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=23 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=20 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=7 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=15 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=14 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 24M 6yrs+
|
172.6 minutes per day
Standard Deviation 40.6
|
105.9 minutes per day
Standard Deviation 57.5
|
40.3 minutes per day
Standard Deviation 18.5
|
34.5 minutes per day
Standard Deviation 50.4
|
18.5 minutes per day
Standard Deviation 30.7
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, baseline <6yrs
|
230.3 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
98.7 minutes per day
Standard Deviation 86.8
|
48.2 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
51.5 minutes per day
Standard Deviation 24.2
|
76.2 minutes per day
Standard Deviation 92.4
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, baseline 6yrs+
|
190.9 minutes per day
Standard Deviation 38.8
|
155.4 minutes per day
Standard Deviation 52.8
|
26.2 minutes per day
Standard Deviation 13.3
|
16.7 minutes per day
Standard Deviation 23.1
|
8.8 minutes per day
Standard Deviation 7.5
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 6M <6yrs
|
198.8 minutes per day
Standard Deviation 63.6
|
122.1 minutes per day
Standard Deviation 83.2
|
37.5 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
60.2 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
28.3 minutes per day
Standard Deviation 54.8
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 6M 6yrs+
|
181.9 minutes per day
Standard Deviation 50.9
|
126.3 minutes per day
Standard Deviation 41.2
|
49.9 minutes per day
Standard Deviation 17.5
|
15.8 minutes per day
Standard Deviation 20.7
|
14.4 minutes per day
Standard Deviation 14.1
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 12M <6yrs
|
222.8 minutes per day
Standard Deviation 43.5
|
111.8 minutes per day
Standard Deviation 64.7
|
56.4 minutes per day
Standard Deviation 11.4
|
75.5 minutes per day
Standard Deviation 34.1
|
38.7 minutes per day
Standard Deviation 51.1
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 12M 6yrs+
|
156.4 minutes per day
Standard Deviation 54.0
|
115.8 minutes per day
Standard Deviation 39.4
|
26.3 minutes per day
Standard Deviation 14.1
|
24.0 minutes per day
Standard Deviation 27.9
|
19.4 minutes per day
Standard Deviation 15.9
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 18M <6yrs
|
230.0 minutes per day
Standard Deviation 17.2
|
56.2 minutes per day
Standard Deviation 17.5
|
117.2 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
82.2 minutes per day
Standard Deviation 68.5
|
49.5 minutes per day
Standard Deviation 59.2
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 18M 6yrs+
|
166.2 minutes per day
Standard Deviation 57.0
|
113.3 minutes per day
Standard Deviation 51.9
|
32.6 minutes per day
Standard Deviation 9.7
|
25.1 minutes per day
Standard Deviation 31.1
|
14.9 minutes per day
Standard Deviation 17.8
|
|
Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
Actigraph: min of Mod-Vig phys act, 24M <6yrs
|
144.0 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
53.6 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
147.3 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
119.7 minutes per day
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
82.9 minutes per day
Standard Deviation 28.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24-monthsPopulation: Actigraph data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).
Participants wore a 3-dimensional accelerometer (Actigraph wGT3X) on their dominant wrist for a seven-day sample. Specific variables reported are average physical activity in raw activity counts per minute for a seven-day sample. The wrist mounted Actigraph counts were converted to waist worn activity counts.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=23 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=20 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=7 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=15 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=14 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 18M <6yrs
|
5132.5 counts per minute
Standard Deviation 512.3
|
2351.2 counts per minute
Standard Deviation 236.0
|
4002.0 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
3217.0 counts per minute
Standard Deviation 1320.1
|
2358.8 counts per minute
Standard Deviation 1657.8
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, baseline <6yrs
|
4642.6 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
3219.6 counts per minute
Standard Deviation 1382.8
|
2560.7 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
2797.6 counts per minute
Standard Deviation 694.2
|
3399.5 counts per minute
Standard Deviation 2354.2
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, baseline 6yrs
|
4655.4 counts per minute
Standard Deviation 911.5
|
3556.4 counts per minute
Standard Deviation 554.1
|
2012.7 counts per minute
Standard Deviation 69.6
|
1567.4 counts per minute
Standard Deviation 722.2
|
1321.4 counts per minute
Standard Deviation 656.1
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 6M <6yrs
|
4519.4 counts per minute
Standard Deviation 1032.4
|
3182.5 counts per minute
Standard Deviation 1650.7
|
2785.6 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
2843.0 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
1687.6 counts per minute
Standard Deviation 1271.4
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 6M 6yrs+
|
4258.2 counts per minute
Standard Deviation 755.7
|
3502.8 counts per minute
Standard Deviation 760.6
|
2524.7 counts per minute
Standard Deviation 429.8
|
1775.5 counts per minute
Standard Deviation 925.2
|
1737.0 counts per minute
Standard Deviation 1080.6
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 12M <6yrs
|
4902.1 counts per minute
Standard Deviation 805.3
|
3504.8 counts per minute
Standard Deviation 932.7
|
2353.2 counts per minute
Standard Deviation 511.0
|
3065.8 counts per minute
Standard Deviation 1142.1
|
2810.5 counts per minute
Standard Deviation 1276.7
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 12M 6yrs+
|
3587.2 counts per minute
Standard Deviation 1349.9
|
3337.5 counts per minute
Standard Deviation 742.7
|
2098.6 counts per minute
Standard Deviation 563.1
|
1813.5 counts per minute
Standard Deviation 826.4
|
1687.8 counts per minute
Standard Deviation 752.5
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 18M 6yrs+
|
4146.1 counts per minute
Standard Deviation 1081.0
|
3280.7 counts per minute
Standard Deviation 883.3
|
2286.8 counts per minute
Standard Deviation 298.9
|
1835.5 counts per minute
Standard Deviation 821.8
|
1561.2 counts per minute
Standard Deviation 768.0
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 24M <6yrs
|
3454.9 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
2107.4 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
4211.5 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
4426.1 counts per minute
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
3292.2 counts per minute
Standard Deviation 404.8
|
|
Physical Activity Measurement: Actigraph: Average Physical Activity
Actigraph: AVG phys act counts/min, 24M 6yrs+
|
4090.3 counts per minute
Standard Deviation 678.8
|
3123.7 counts per minute
Standard Deviation 866.2
|
2234.2 counts per minute
Standard Deviation 616.3
|
1835.3 counts per minute
Standard Deviation 934.8
|
1285.6 counts per minute
Standard Deviation 639.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24-monthsPopulation: The 1MPT and 6MPT were administered for exploratory purposes in the Physical Activity Measurement sub-study. The available N at each time point = 5 children or fewer. Not every child was tested at every time point.
The 1MPT to 6MPT are submaximal, clinical exercise tests, in which the total distance propelled in a manual wheelchair in 1-minute and 6-minutes, under controlled conditions, are measured for children who use a manual wheelchair for mobility (GMFCS level II, III, IV), the 1MPT/6MPT was conducted indoors or outdoors on a large, flat, hard terrain. A surveyor's measure wheel was used to calculate the total distance wheeled and a stopwatch to keep track of the allocated time. Standardized directions were used to encourage the child to wheel as far as possible. Distances wheeled (# of feet) are reported for a small number of participants within the Physical Activity sub-study.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=2 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=2 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=1 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, Baseline: under 6 years
|
—
|
1111.50 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
146.19 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
391.30 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, Baseline: under 6 years
|
—
|
185.26 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
22.50 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
85.50 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, Baseline: 6 years and older
|
—
|
232.20 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
86.00 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, 6-month assessment: under 6 years
|
—
|
—
|
45.60 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
89.10 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, 6-month assessment: 6 years and older
|
—
|
—
|
78.60 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, 12-month assessment: under 6 years
|
—
|
—
|
—
|
49.48 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, 12-month assessment: 6 years and older
|
—
|
—
|
101.85 Feet
Standard Deviation 25.24
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, 18-month assessment: 6 years and older
|
—
|
239.00 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
131.35 Feet
Standard Deviation 44.05
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, Baseline: 6 years and older
|
—
|
1296.20 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
926.00 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
1MPT, 24-month assessment: 6 years and older
|
—
|
—
|
95.60 Feet
Standard Deviation 17.54
|
131.80 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, 6-month assessment: under 6 years
|
—
|
—
|
177.10 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
394.50 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, 6-month assessment: 6 years and older
|
—
|
—
|
435.50 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, 12-month assessment: under 6 years
|
—
|
—
|
—
|
296.89 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, 12-month assessment: 6 years and older
|
—
|
—
|
597.75 Feet
Standard Deviation 71.77
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, 18-month assessment: 6 years and older
|
—
|
1525.70 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
587.95 Feet
Standard Deviation 133.57
|
—
|
—
|
|
1 Minute to 6 Minute Push Test (1MPT, 6MPT)
6MPT, 24-month assessment: 6 years and older
|
—
|
—
|
422.85 Feet
Standard Deviation 282.06
|
546.50 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24-monthsPopulation: This test was administered for exploratory purposes in the Physical Activity Measurement sub-study. The available N at each time point is 4 or fewer. Also there are two age levels reported at each assessment time and children fell into only one of the two age groups.
The 1SPT is a clinical exercise test, in which the distance rolled in a manual wheelchair, under controlled conditions, with one push using both hands if possible is measured. Within this study a subsample of children who used a manual wheelchair for mobility (GMFCS levels III, IV) were tested on this measure. A surveyor's measure wheel will be used to calculate the total distance (# of feet) wheeled. Standardized directions are used to encourage the child to wheel as far as possible.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=11 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=4 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
1 Stroke Push Test (1SPT)
1SPT, Baseline: under 6 years
|
—
|
—
|
8.87 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
0.63 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Stroke Push Test (1SPT)
1SPT, Baseline: 6 years and older
|
—
|
—
|
5.73 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
1 Stroke Push Test (1SPT)
1SPT 6-month assessment: under 6 years
|
—
|
—
|
10.87 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
1.40 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Stroke Push Test (1SPT)
1SPT 6-month assessment: 6 years and older
|
—
|
—
|
16.53 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
—
|
|
1 Stroke Push Test (1SPT)
1SPT 12-month assessment: under 6 years
|
—
|
—
|
—
|
1.43 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
|
1 Stroke Push Test (1SPT)
1SPT 12-month assessment: 6 years and older
|
—
|
—
|
6.30 Feet
Standard Deviation 0.79
|
—
|
—
|
|
1 Stroke Push Test (1SPT)
1SPT 18-month assessment: 6 years and older
|
—
|
—
|
10.29 Feet
Standard Deviation 5.02
|
—
|
—
|
|
1 Stroke Push Test (1SPT)
1SPT 24-month assessment: 6 years and older
|
—
|
—
|
12.01 Feet
Standard Deviation 4.14
|
2.10 Feet
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24-monthsPopulation: Caregiver PEM-CY data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).
The PEM-CY environment section is a caregiver completed 45-item questionnaire about the facilitators and barriers that might impact the child's participation in the home, school, and community environments. Twenty-five items include ratings on things that help or make it harder for the child to participate in activities in each environment (4-point scale from "not an issue" to "usually makes harder"). Twenty items include ratings of the availability of supports for the child's participation in each environment (4-point scale from "not needed" to "usually no"). Caregivers can also write in what family members do that help the child participate. A percentage score representing support for participation for each setting is calculated. The higher the percentage the more support the environment provides for the child's participation within the setting.
Outcome measures
| Measure |
Gross Motor Function Classification System (GMFCS) Level I
n=23 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level II
n=20 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: II: Walks with limitations. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level III
n=7 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: III: Walks using a handheld mobility device. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level IV
n=15 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: IV: Self mobility with Limitations; may use powered mobility. Descriptors for five levels vary by the age of the child.
|
Gross Motor Function Classification System (GMFCS) Level V
n=14 Participants
The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: V: Transported in manual wheelchair. Descriptors for five levels vary by the age of the child.
|
|---|---|---|---|---|---|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 24M 6yrs+
|
93.8 percentage of support for participation
Standard Deviation 9.2
|
85.7 percentage of support for participation
Standard Deviation 10.4
|
80.8 percentage of support for participation
Standard Deviation 6.5
|
75.8 percentage of support for participation
Standard Deviation 12.7
|
75.6 percentage of support for participation
Standard Deviation 12.2
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: baseline <6yrs
|
70 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
91.0 percentage of support for participation
Standard Deviation 8.5
|
85.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
69.6 percentage of support for participation
Standard Deviation 10.3
|
73.3 percentage of support for participation
Standard Deviation 9.4
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: baseline 6yrs+
|
92.0 percentage of support for participation
Standard Deviation 7.4
|
78.0 percentage of support for participation
Standard Deviation 12.6
|
71.5 percentage of support for participation
Standard Deviation 9.2
|
81.7 percentage of support for participation
Standard Deviation 14.7
|
79.7 percentage of support for participation
Standard Deviation 9.6
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 6M <6yrs
|
93.2 percentage of support for participation
Standard Deviation 7.5
|
88.5 percentage of support for participation
Standard Deviation 1.0
|
88.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
70.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
77.8 percentage of support for participation
Standard Deviation 11.6
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 6M 6yrs+
|
93.6 percentage of support for participation
Standard Deviation 8.7
|
79.7 percentage of support for participation
Standard Deviation 7.3
|
80.0 percentage of support for participation
Standard Deviation 8.7
|
77.9 percentage of support for participation
Standard Deviation 11.4
|
78.4 percentage of support for participation
Standard Deviation 13.1
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 12M <6yrs
|
87.8 percentage of support for participation
Standard Deviation 14.3
|
93.5 percentage of support for participation
Standard Deviation 4.9
|
86.0 percentage of support for participation
Standard Deviation 8.5
|
73.7 percentage of support for participation
Standard Deviation 7.5
|
81.8 percentage of support for participation
Standard Deviation 17.1
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 12M 6yrs+
|
93.0 percentage of support for participation
Standard Deviation 9.1
|
84.0 percentage of support for participation
Standard Deviation 11.7
|
92.8 percentage of support for participation
Standard Deviation 4.8
|
79.0 percentage of support for participation
Standard Deviation 12.5
|
75.9 percentage of support for participation
Standard Deviation 11.2
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 18M <6yrs
|
87.7 percentage of support for participation
Standard Deviation 15.7
|
96.5 percentage of support for participation
Standard Deviation 2.1
|
90.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
92.0 percentage of support for participation
Standard Deviation 8.5
|
65.4 percentage of support for participation
Standard Deviation 16.7
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 18M 6yrs+
|
95.1 percentage of support for participation
Standard Deviation 9.1
|
87.3 percentage of support for participation
Standard Deviation 10.3
|
88.6 percentage of support for participation
Standard Deviation 10.9
|
71.8 percentage of support for participation
Standard Deviation 14.2
|
78.2 percentage of support for participation
Standard Deviation 10.2
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation HOME: 24M <6yrs
|
86.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
85.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
83.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
75.6 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
68.2 percentage of support for participation
Standard Deviation 2.6
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: baseline <6yrs
|
68.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
74.0 percentage of support for participation
Standard Deviation 20.4
|
85.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
61.2 percentage of support for participation
Standard Deviation 12.6
|
59.5 percentage of support for participation
Standard Deviation 3.5
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: baseline 6yrs+
|
88.4 percentage of support for participation
Standard Deviation 13.6
|
70.9 percentage of support for participation
Standard Deviation 11.3
|
64.5 percentage of support for participation
Standard Deviation 3.5
|
65.2 percentage of support for participation
Standard Deviation 13.6
|
73.3 percentage of support for participation
Standard Deviation 7.8
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 6M <6yrs
|
81.6 percentage of support for participation
Standard Deviation 11.1
|
81.2 percentage of support for participation
Standard Deviation 8.3
|
85.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
48.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
69.8 percentage of support for participation
Standard Deviation 12.7
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 6M 6yrs+
|
90.4 percentage of support for participation
Standard Deviation 9.1
|
68.0 percentage of support for participation
Standard Deviation 15.3
|
62.0 percentage of support for participation
Standard Deviation 8.5
|
68.3 percentage of support for participation
Standard Deviation 14.6
|
74.6 percentage of support for participation
Standard Deviation 17.7
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 12M <6yrs
|
84.5 percentage of support for participation
Standard Deviation 12.0
|
86.0 percentage of support for participation
Standard Deviation 12.6
|
79.0 percentage of support for participation
Standard Deviation 1.4
|
61.0 percentage of support for participation
Standard Deviation 7.2
|
73.5 percentage of support for participation
Standard Deviation 16.0
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 12M 6yrs+
|
86.8 percentage of support for participation
Standard Deviation 11.4
|
72.4 percentage of support for participation
Standard Deviation 15.9
|
72.4 percentage of support for participation
Standard Deviation 14.7
|
66.7 percentage of support for participation
Standard Deviation 13.9
|
67.2 percentage of support for participation
Standard Deviation 16.1
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 18M <6yrs
|
91.7 percentage of support for participation
Standard Deviation 7.6
|
80.0 percentage of support for participation
Standard Deviation 0.0
|
75.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
60.0 percentage of support for participation
Standard Deviation 4.4
|
61.9 percentage of support for participation
Standard Deviation 13.7
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 18M 6yrs+
|
89.4 percentage of support for participation
Standard Deviation 10.8
|
73.9 percentage of support for participation
Standard Deviation 17.2
|
73.0 percentage of support for participation
Standard Deviation 9.1
|
65.7 percentage of support for participation
Standard Deviation 12.7
|
70.9 percentage of support for participation
Standard Deviation 12.1
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 24M <6yrs
|
87.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
83.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
75.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
59.9 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
59.1 percentage of support for participation
Standard Deviation 1.5
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation COMMUNITY: 24M 6yrs+
|
90.0 percentage of support for participation
Standard Deviation 8.6
|
68.4 percentage of support for participation
Standard Deviation 23.8
|
67.5 percentage of support for participation
Standard Deviation 7.5
|
67.0 percentage of support for participation
Standard Deviation 13.7
|
66.4 percentage of support for participation
Standard Deviation 10.9
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: baseline <6yrs
|
72.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
73.3 percentage of support for participation
Standard Deviation 26.3
|
80.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
66.9 percentage of support for participation
Standard Deviation 11.4
|
68.5 percentage of support for participation
Standard Deviation 0.7
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: baseline 6yrs+
|
85.0 percentage of support for participation
Standard Deviation 8.0
|
76.6 percentage of support for participation
Standard Deviation 11.9
|
71.5 percentage of support for participation
Standard Deviation 2.1
|
76.7 percentage of support for participation
Standard Deviation 10.7
|
81.0 percentage of support for participation
Standard Deviation 10.8
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 6M <6yrs
|
83.8 percentage of support for participation
Standard Deviation 13.5
|
89.5 percentage of support for participation
Standard Deviation 4.2
|
86.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
73.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
70.0 percentage of support for participation
Standard Deviation 6.6
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 6M 6yrs+
|
87.4 percentage of support for participation
Standard Deviation 9.3
|
74.2 percentage of support for participation
Standard Deviation 11.9
|
72.3 percentage of support for participation
Standard Deviation 12.2
|
74.7 percentage of support for participation
Standard Deviation 15.1
|
81.5 percentage of support for participation
Standard Deviation 12.1
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 12M <6yrs
|
87.0 percentage of support for participation
Standard Deviation 12.4
|
93.0 percentage of support for participation
Standard Deviation 9.1
|
79.4 percentage of support for participation
Standard Deviation 6.5
|
70.0 percentage of support for participation
Standard Deviation 3.0
|
73.2 percentage of support for participation
Standard Deviation 11.9
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 12M 6yrs+
|
87.6 percentage of support for participation
Standard Deviation 10.8
|
75.5 percentage of support for participation
Standard Deviation 14.4
|
75.2 percentage of support for participation
Standard Deviation 9.2
|
75.0 percentage of support for participation
Standard Deviation 9.5
|
77.8 percentage of support for participation
Standard Deviation 12.7
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 18M <6yrs
|
94.3 percentage of support for participation
Standard Deviation 4.9
|
83.5 percentage of support for participation
Standard Deviation 0.7
|
70.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
76.3 percentage of support for participation
Standard Deviation 4.0
|
68.3 percentage of support for participation
Standard Deviation 5.6
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 18M 6yrs+
|
89.2 percentage of support for participation
Standard Deviation 7.9
|
77.2 percentage of support for participation
Standard Deviation 14.5
|
78.4 percentage of support for participation
Standard Deviation 13.5
|
71.6 percentage of support for participation
Standard Deviation 10.1
|
74.6 percentage of support for participation
Standard Deviation 11.0
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 24M <6yrs
|
80.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
91.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
75.0 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
69.1 percentage of support for participation
Standard Deviation NA
N/A when there is only 1 case in the cell therefore there is no standard deviation
|
67.9 percentage of support for participation
Standard Deviation 1.3
|
|
Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
Support Participation SCHOOL: 24M 6yrs+
|
89.7 percentage of support for participation
Standard Deviation 10.2
|
78.0 percentage of support for participation
Standard Deviation 13.6
|
74.8 percentage of support for participation
Standard Deviation 12.5
|
71.9 percentage of support for participation
Standard Deviation 12.4
|
71.8 percentage of support for participation
Standard Deviation 7.4
|
Adverse Events
Gross Motor Function Classification System (GMFCS) Level I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gross Motor Function Classification System (GMFCS) Level II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gross Motor Function Classification System (GMFCS) Level III
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gross Motor Function Classification System (GMFCS) Level IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Gross Motor Function Classification System (GMFCS) Level V
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Westcott McCoy PT, PhD, FAPTA
University of Washington
Phone: 206-616-8601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place