Cerebral Palsy Early Mobility Training (iMOVE)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Conventional Therapy; Other: Dynamic Supported Mobility

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02340026

14-011172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Conventional Therapy

Experimental group

Description:

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.

Treatment:

Other: Conventional Therapy

Dynamic Supported Mobility

Experimental group

Description:

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.

Treatment:

Other: Dynamic Supported Mobility