Cerebral Palsy Early Mobility Training

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal treatment duration of a novel early mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of treatment; and to evaluate the clinical futility of this intervention compared to current rehabilitation practice.

Detailed Description
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This study is a single-blind, randomized exploratory clinical trial with repeated assessments during a 24-week treatment phase and at three follow-up points over 12 months after treatment to track the developmental trajectory of participants' motor function. Gross motor ability will be compared to published percentile scores of motor function development in cerebral palsy (CP) to determine if the trajectory of predicted motor development is altered, and to outcomes of intensity-matched conventional treatment to determine if continued Phase III investigation is warranted.

Official Title
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Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Dynamic Supported Mobility
* Other: Conventional Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12-36 months of age Gross motor function below the 10th percentile for age [Bayley Scales of Infant and Toddler Development (BSID), BSID-III, corrected for gestational age, if applicable, under the age of two years]. Diagnosis of CP or neurological sign associated with CP (i.e. spasticity). Ability to initiate pulling to stand at a surface (Score of 1 on GMFM Item 52). Cognitive ability to follow one-step commands. Exclusion Criteria: Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP. General muscle hypotonia, without other neurological signs associated with CP. Independent walking ability (Score of 3 on GMFM Item 69 - Walks forward 10 steps). At or above the 50th percentile of GMFCS Level I. History of surgery or injury to the lower extremities in the past 6 months.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Therapy<br>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. | Other: Conventional Therapy<br>* 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<br>|
| Experimental: Dynamic Supported Mobility<br>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. | Other: Dynamic Supported Mobility<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gross Motor Function Measure (GMFM-66) | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postural control | Using computerized posturography, participants will sit for 3-5 ten second trials on the force platform while center of pressure data are collected. This process will be repeated in kneeling and standing positions if the participant is able to maintain these positions. Center of pressure data will be interpreted using nonlinear measures of analysis. | Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends | 
| Change in physical activity | 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 using corresponding software. | Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends | 
| Change in caregiver satisfaction | 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. | Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends | 
| Change in Child Engagement in Daily Life | 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. | Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends | 
| Change in Gross Motor Function Measure (GMFM-66) |  | Weeks 0, 6, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delay in motor skill development