Cerebral Palsy Early Mobility Training

Children's Hospital of Philadelphia42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy

Interventions

Dynamic Supported MobilityOTHER

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

Conventional TherapyOTHER

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 36 Months

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase

Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. This score will also be used with the patient's age to determine Gross Motor Function Classification System (GMFCS) percentile rank. Scores range from 0 (no volitional movement) to 100 (gross motor function of an average 5 year old). Higher scores reflect better outcomes.

Time frame: Baseline and 12 weeks

Secondary Outcomes

Change in Postural Control

Early Clinical Assessment of Balance - a clinical test of balance and postural control developed for administration with young children. The minimum score is 0. The maximum score is 100. Higher scores reflect better postural control.

Time frame: Baseline and 12 weeks

Change in Physical Activity

A wireless activity monitor will be provided to the caregiver, who will be instructed on use of the monitor at home, with a goal of recording 5 total hours of the child's free play in the following week. Amount and magnitude of physical activity will be calculated from the acceleration time series using signal processing software.

Time frame: Weeks 0 and 12

Change in Caregiver Satisfaction

Using the Canadian Occupational Performance Measure, one caregiver of each participant will rate their child's performance on the caregiver's self-identified goals, and then rate their own (caregiver's) satisfaction with the child's performance. Satisfaction is rated on a scale of 1-10, with higher ratings reflecting greater parent satisfaction.

Time frame: Baseline and 12 weeks

Change in Child Engagement in Daily Life

One caregiver of each participant will complete the Child Engagement in Daily Life Measure to obtain a measure of the child's participation in play in daily life. Scaled scores range from 0-100. Higher scores reflect greater engagement in daily life.

Data from ClinicalTrials.gov

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