Trial Outcomes & Findings for Cerebral Palsy Early Mobility Training (NCT NCT02340026)
NCT ID: NCT02340026
Last Updated: 2025-11-04
Results Overview
Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. This score will also be used with the patient's age to determine Gross Motor Function Classification System (GMFCS) percentile rank. Scores range from 0 (no volitional movement) to 100 (gross motor function of an average 5 year old). Higher scores reflect better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2025-11-04
Participant Flow
Participants were enrolled from January 2015 through January 2019. The primary sources of recruitment were the Cerebral Palsy, outpatient physical therapy and Neonatal Follow-up programs at our institution.
Full baseline assessment not completed (n=1)
Participant milestones
| Measure |
Conventional Therapy
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility (DSM)
Children will receive dynamic weight support during all Dynamic Supported Mobility (DSM) treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Follow-up Phase
COMPLETED
|
18
|
18
|
|
Follow-up Phase
NOT COMPLETED
|
1
|
0
|
|
Treatment Phase
STARTED
|
21
|
20
|
|
Treatment Phase
COMPLETED
|
19
|
18
|
|
Treatment Phase
NOT COMPLETED
|
2
|
2
|
|
Follow-up Phase
STARTED
|
19
|
18
|
Reasons for withdrawal
| Measure |
Conventional Therapy
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility (DSM)
Children will receive dynamic weight support during all Dynamic Supported Mobility (DSM) treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
2
|
2
|
|
Follow-up Phase
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Cerebral Palsy Early Mobility Training
Baseline characteristics by cohort
| Measure |
Conventional Therapy
n=21 Participants
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility
n=20 Participants
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=15 Participants
|
20 Participants
n=161 Participants
|
41 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Continuous
|
23.2 months
STANDARD_DEVIATION 7.2 • n=15 Participants
|
20.4 months
STANDARD_DEVIATION 5.1 • n=161 Participants
|
21.8 months
STANDARD_DEVIATION 6.3 • n=100 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants
|
8 Participants
n=161 Participants
|
18 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
12 Participants
n=161 Participants
|
23 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=15 Participants
|
17 Participants
n=161 Participants
|
36 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants
|
7 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=15 Participants
|
12 Participants
n=161 Participants
|
27 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=15 Participants
|
20 Participants
n=161 Participants
|
41 Participants
n=100 Participants
|
|
Gross Motor Function Classification System (GMFCS)
I
|
3 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
|
Gross Motor Function Classification System (GMFCS)
II
|
9 Participants
n=15 Participants
|
8 Participants
n=161 Participants
|
17 Participants
n=100 Participants
|
|
Gross Motor Function Classification System (GMFCS)
III
|
5 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Gross Motor Function Classification System (GMFCS)
IV
|
4 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
|
Gross Motor Function Classification System (GMFCS)
V
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Anatomical typography
Monoplegia
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Anatomical typography
Hemiplegia
|
5 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
8 Participants
n=100 Participants
|
|
Anatomical typography
Diplegia
|
10 Participants
n=15 Participants
|
8 Participants
n=161 Participants
|
18 Participants
n=100 Participants
|
|
Anatomical typography
Triplegia
|
1 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
|
Anatomical typography
Quadriplegia
|
4 Participants
n=15 Participants
|
6 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Anatomical typography
Unknown
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants with completed baseline and 12 week assessments
Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. This score will also be used with the patient's age to determine Gross Motor Function Classification System (GMFCS) percentile rank. Scores range from 0 (no volitional movement) to 100 (gross motor function of an average 5 year old). Higher scores reflect better outcomes.
Outcome measures
| Measure |
Conventional Therapy
n=19 Participants
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility
n=18 Participants
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase
|
2.2 units on a scale
Standard Deviation 3.2
|
3.5 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All participants with baseline and 12 week scores
Early Clinical Assessment of Balance - a clinical test of balance and postural control developed for administration with young children. The minimum score is 0. The maximum score is 100. Higher scores reflect better postural control.
Outcome measures
| Measure |
Conventional Therapy
n=19 Participants
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility
n=18 Participants
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Change in Postural Control
|
2.7 ECAB score units
Standard Deviation 4.7
|
4.3 ECAB score units
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Weeks 0 and 12Population: All participants with evaluable data from using the wearable sensors at home at Times 0 and 12 weeks.
A wireless activity monitor will be provided to the caregiver, who will be instructed on use of the monitor at home, with a goal of recording 5 total hours of the child's free play in the following week. Amount and magnitude of physical activity will be calculated from the acceleration time series using signal processing software.
Outcome measures
| Measure |
Conventional Therapy
n=9 Participants
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility
n=7 Participants
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Change in Physical Activity
|
1.4 change in percent active time
Standard Deviation 8.9
|
-2.6 change in percent active time
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All participants with baseline and 12 week scores
Using the Canadian Occupational Performance Measure, one caregiver of each participant will rate their child's performance on the caregiver's self-identified goals, and then rate their own (caregiver's) satisfaction with the child's performance. Satisfaction is rated on a scale of 1-10, with higher ratings reflecting greater parent satisfaction.
Outcome measures
| Measure |
Conventional Therapy
n=19 Participants
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility
n=18 Participants
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Change in Caregiver Satisfaction
|
1.5 COPM score units
Standard Deviation 2.7
|
2.5 COPM score units
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All participants with baseline and 12 week scores
One caregiver of each participant will complete the Child Engagement in Daily Life Measure to obtain a measure of the child's participation in play in daily life. Scaled scores range from 0-100. Higher scores reflect greater engagement in daily life.
Outcome measures
| Measure |
Conventional Therapy
n=18 Participants
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility
n=18 Participants
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Change in Child Engagement in Daily Life
|
0.96 CEDL scaled score units
Standard Deviation 7.1
|
3.8 CEDL scaled score units
Standard Deviation 6.1
|
Adverse Events
Conventional Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dynamic Supported Mobility
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Therapy
n=21 participants at risk
The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of "normal" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.
Conventional Therapy: No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
|
Dynamic Supported Mobility
n=20 participants at risk
Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.
Dynamic Supported Mobility: Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall in a toddler
|
14.3%
3/21 • Number of events 3 • Enrollment to study completion (up to 18 months)
|
5.0%
1/20 • Number of events 1 • Enrollment to study completion (up to 18 months)
|
Additional Information
Laura A. Prosser, PT, PhD
The Children's Hospital of Philadelphia
Phone: 215-590-2495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place