Clinical trial NCT02340026: Cerebral Palsy Early Mobility Training
Official title: Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Delay in motor skill development
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2015-01-16
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 \[Score of 1 on gross motor function measure (GMFM) Item 52\].
* 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.

Primary outcomes:
measure: Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Postural Control
timeFrame: Baseline and 12 weeks
measure: Change in Physical Activity
timeFrame: Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
measure: Change in Caregiver Satisfaction
timeFrame: Baseline and 12 weeks
measure: Change in Child Engagement in Daily Life
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Laura Prosser, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prosser LA, Pierce SR, Skorup JA, Paremski AC, Alcott M, Bochnak M, Ruwaih N, Jawad AF. Motor training for young children with cerebral palsy: A single-blind randomized controlled trial. Dev Med Child Neurol. 2024 Feb;66(2):233-243. doi: 10.1111/dmcn.15729. Epub 2023 Aug 7.
citation: Prosser LA, Pierce SR, Dillingham TR, Bernbaum JC, Jawad AF. iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial. BMC Pediatr. 2018 Oct 16;18(1):329. doi: 10.1186/s12887-018-1303-8.