Cerebral Palsy Early Mobility Training
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/22/2018 |
Start Date: | January 15, 2015 |
End Date: | March 2019 |
Contact: | Jennifer Swope |
Email: | swopej@email.chop.edu |
Phone: | 267-426-7803 |
Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy
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.
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.
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.
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.
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.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Laura Prosser, PT, PhD
Phone: 267-426-7803
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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