Cerebral Palsy Early Mobility Training
- Conditions
- Cerebral Palsy
- Interventions
- Other: Dynamic Supported MobilityOther: Conventional Therapy
- Registration Number
- NCT02340026
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dynamic Supported Mobility Dynamic Supported Mobility 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. Conventional Therapy 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.
- Primary Outcome Measures
Name Time Method Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase Baseline and 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in Postural Control Baseline and 12 weeks 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.
Change in Physical Activity Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends 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. These data are still being analyzed.
Change in Caregiver Satisfaction Baseline and 12 weeks 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.
Change in Child Engagement in Daily Life Baseline and 12 weeks 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.
Trial Locations
- Locations (1)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States