Trials / Completed
CompletedNCT02340026
Cerebral Palsy Early Mobility Training
Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- 12 Months – 36 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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 |
| OTHER | 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 |
Timeline
- Start date
- 2015-01-15
- Primary completion
- 2019-04-01
- Completion
- 2020-07-13
- First posted
- 2015-01-16
- Last updated
- 2025-11-04
- Results posted
- 2024-09-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02340026. Inclusion in this directory is not an endorsement.