Trial Outcomes & Findings for Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy (NCT NCT02424526)
NCT ID: NCT02424526
Last Updated: 2020-07-02
Results Overview
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.
COMPLETED
NA
19 participants
assessed at 6 weeks, 1 month, 4 months from baseline
2020-07-02
Participant Flow
Participant milestones
| Measure |
High-intensity Group
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
Baseline characteristics by cohort
| Measure |
High-intensity Group
n=9 Participants
High-intensity engaged in treadmill training 10x/week for 6 weeks
|
Low-intensity Group
n=10 Participants
Low-intensity engaged in treadmill training 2x/week for 6 weeks
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African-American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
10 participants
n=4 Participants
|
19 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: assessed at 6 weeks, 1 month, 4 months from baselineThe Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.
Outcome measures
| Measure |
High-intensity Group
n=9 Participants
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
n=10 Participants
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
Gross Motor Function Measure Dimension E
6 weeks
|
15.6 score on a scale
Standard Deviation 5.9
|
12.7 score on a scale
Standard Deviation 9.7
|
|
Gross Motor Function Measure Dimension E
1 month
|
18.7 score on a scale
Standard Deviation 7.5
|
17.1 score on a scale
Standard Deviation 8.8
|
|
Gross Motor Function Measure Dimension E
4 months
|
16.2 score on a scale
Standard Deviation 5.9
|
14.1 score on a scale
Standard Deviation 7.7
|
PRIMARY outcome
Timeframe: StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported.
Outcome measures
| Measure |
High-intensity Group
n=9 Participants
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
n=10 Participants
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
Walking Activity Measured by StepWatch
6 weeks
|
39.43 minutes
Interval -60.76 to 139.6
|
25.09 minutes
Interval -5.02 to 55.2
|
|
Walking Activity Measured by StepWatch
1 month
|
83.33 minutes
Interval -20.8 to 187.46
|
18.01 minutes
Interval -12.1 to 48.12
|
|
Walking Activity Measured by StepWatch
4 months
|
132.00 minutes
Interval 27.86 to 236.14
|
41.19 minutes
Interval 7.17 to 75.21
|
PRIMARY outcome
Timeframe: assessed at 6 weeks, 1 month, 4 months from baselineThe Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported.
Outcome measures
| Measure |
High-intensity Group
n=9 Participants
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
n=10 Participants
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
Gross Motor Function Measure Dimension D
6 weeks
|
5.11 score on a scale
Interval 1.05 to 9.17
|
5.30 score on a scale
Interval 2.37 to 8.23
|
|
Gross Motor Function Measure Dimension D
1 month
|
8.22 score on a scale
Interval 4.16 to 12.28
|
8.72 score on a scale
Interval 5.67 to 11.76
|
|
Gross Motor Function Measure Dimension D
4 months
|
12.67 score on a scale
Interval 8.6 to 16.73
|
12.94 score on a scale
Interval 9.89 to 15.99
|
SECONDARY outcome
Timeframe: pre-intervention, at 6 weeks, at 1-month and at 4-months following the interventionThe Pediatric Evaluation of Disability Index is a valid and reliable tool that provides an assessment of a child's functional status and performance via observation and parent report.The Mobility Subscale examines the child's functional skills related to movement. There are a total of 13 motor categories on the Mobility Subscale, with 5 possible motor skills in each category, for a total of 65 distinct motor skills. Skills are marked as 0 (not observed) or 1 (observed) and added.There are a total of 65 possible points with a range of 0-65 points on the Mobility Subscale. Higher scores indicate greater function.Scores are reported as changes from baseline.
Outcome measures
| Measure |
High-intensity Group
n=9 Participants
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
n=10 Participants
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
Pediatric Evaluation of Disability Index-Mobility Subscale
6 weeks
|
3.80 score on a scale
Interval 1.41 to 6.1
|
5.44 score on a scale
Interval 1.81 to 9.0
|
|
Pediatric Evaluation of Disability Index-Mobility Subscale
1 month
|
6.89 score on a scale
Interval 3.26 to 10.0
|
7.51 score on a scale
Interval 5.03 to 10.0
|
|
Pediatric Evaluation of Disability Index-Mobility Subscale
4 months
|
11.63 score on a scale
Interval 9.14 to 14.11
|
14.00 score on a scale
Interval 10.37 to 17.63
|
SECONDARY outcome
Timeframe: assessed at 6 weeks, at 1-month and at 4-months following the interventionThe child's walking speed is recorded over 10 meters if the child is able to walk with or without an assistive device. The speed is timed and reported in seconds. Fewer seconds indicate a faster walking speed. Time in seconds is reported as change from baseline.
Outcome measures
| Measure |
High-intensity Group
n=9 Participants
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
n=10 Participants
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
Timed 10-meter Walk Test
6 weeks
|
-24.86 seconds
Interval -44.12 to -5.6
|
-36.23 seconds
Interval -62.66 to -9.81
|
|
Timed 10-meter Walk Test
1 month
|
-28.16 seconds
Interval -47.42 to -8.9
|
-49.65 seconds
Interval -77.01 to -22.12
|
|
Timed 10-meter Walk Test
4 months
|
-46.99 seconds
Interval -66.25 to -27.73
|
-38.80 seconds
Interval -66.25 to -11.36
|
SECONDARY outcome
Timeframe: assessed at 6 weeks, at 1-month and at 4-monthsPeabody Developmental Motor Scales-2 is a norm-referenced standardized test of gross and fine motor performance for children from birth through age 5.The Locomotion Subscale examines the ability of the child to move through space. It contains a total of 89 motor skills. The child is rated on each skill on a scale of 0 (unable), 1 (partial) or 2 (complete) and the scores are added for a total possible raw score of 178 and a range of 0-178. Higher raw scores indicate a better outcome.The raw scores can be converted to standard scores, age equivalents and percentiles Raw scores of the Locomotion subscale are reported based on changes from baseline.
Outcome measures
| Measure |
High-intensity Group
n=9 Participants
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
n=10 Participants
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
Peabody Developmental Motor Scales-2 -Locomotion Subscale
4 months
|
14.11 score on a scale
Interval 9.32 to 18.9
|
13.99 score on a scale
Interval 10.33 to 17.65
|
|
Peabody Developmental Motor Scales-2 -Locomotion Subscale
6 weeks
|
5.67 score on a scale
Interval 0.88 to 10.46
|
6.70 score on a scale
Interval 3.18 to 10.22
|
|
Peabody Developmental Motor Scales-2 -Locomotion Subscale
1 month
|
8.33 score on a scale
Interval 3.55 to 13.12
|
9.21 score on a scale
Interval 5.55 to 12.88
|
SECONDARY outcome
Timeframe: assessed at 6 weeks, 1 month, 4 monthsThe child's walking distance is measured in meters over 1 minute at their self-selected walking speed if the child is able to walk with or without an assistive device.The walking distance is reported in meters. More meters indicate more distance covered. Values are reported in meters as changes from baseline.
Outcome measures
| Measure |
High-intensity Group
n=9 Participants
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
Low-intensity Group
n=10 Participants
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
home-based treadmill training: the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Treadmill
|
|---|---|---|
|
1-minute Walk Test
6 weeks
|
8.28 meters
Interval 3.49 to 13.09
|
7.87 meters
Interval 1.78 to 13.96
|
|
1-minute Walk Test
1 month
|
12.38 meters
Interval 7.58 to 17.18
|
9.48 meters
Interval 3.15 to 15.8
|
|
1-minute Walk Test
4 months
|
15.37 meters
Interval 10.57 to 20.17
|
16.15 meters
Interval 9.83 to 22.47
|
Adverse Events
High-intensity Group
Low-intensity Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place