Cerebral Palsy Early Mobility Training

Cerebral Palsy Clinical Trial

— iMOVE  

Official title:

Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340026
• Other study ID #: 14-011172
• Status: Completed
• Phase: N/A
• Start date: January 15, 2015
• Est. completion date: July 13, 2020

Study information

• Verified date: August 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 13, 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Dynamic Supported Mobility
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 Therapy
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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gross Motor Function Measure (GMFM-66)	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.	12 weeks
Secondary	Change in postural control	Using computerized posturography, participants will sit for 3-5 ten second trials on the force platform while center of pressure data are collected. This process will be repeated in kneeling and standing positions if the participant is able to maintain these positions. Center of pressure data will be interpreted using nonlinear measures of analysis.	Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Secondary	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 using corresponding software.	Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Secondary	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.	Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Secondary	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.	Weeks 0, 6, 12, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends
Secondary	Change in Gross Motor Function Measure (GMFM-66)		Weeks 0, 6, 18, and 24, then at 3, 6 and 12 month follow-up sessions after treatment ends