Philadelphia, Pennsylvania 19104


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02340026


Primary Contact:

Principal Investigator
Laura Prosser, PT, PhD
Children's Hospital of Philadelphia

Jennifer Swope
Phone: 267-426-7803
Email: swopej@email.chop.edu


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States

Jennifer Swope
Phone: 267-426-7803
Email: swopej@email.chop.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.