Supervised Fitness Program for Adults With Cerebral Palsy
Does Participating in a Supervised Fitness Program Extend the Benefits of Episodic Physical Therapy More Than a Home Exercise Program for Adults With Cerebral Palsy?
1 other identifier
interventional
18
1 country
2
Brief Summary
The purpose of this study is to compare the effectiveness of 2 community intervention approaches to maintain community mobility and walking speed in adults with cerebral palsy who have previously completed an 8 week course of physical therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 17, 2017
CompletedStudy Start
First participant enrolled
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedAugust 7, 2019
August 1, 2019
1.4 years
July 12, 2017
August 5, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score
The PEDI-CAT assesses function in 4 domains: Daily Activity, Mobility, Social/Cognitive, Responsibility
Baseline, 4 weeks, 8 weeks, 12 weeks
Change in Timed Up and Go (TUG) score
Mobility assessment measuring amount of time it takes for participant to get up from chair, walk to a line on the floor at a normal pace, and return to a seated position
Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcomes (1)
Change in six-minute walk test (6MWT)
Baseline, 4 weeks, 8 weeks, 12 weeks
Study Arms (2)
Home Group
OTHERCenter Group
EXPERIMENTALInterventions
The Home group will meet with an exercise professional once and be given a home exercise program to complete 3 to 5 times per weeks at home.
The Center group will be given an exercise program, a membership to a community fitness gym where they will be asked to exercise 3-5 times per week, and will be provided with 6 individual personal training sessions.
Eligibility Criteria
You may qualify if:
- Adults with cerebral palsy Gross Motor Function Classification System (GMFCS) level I, II, or III
- Completion of episode of physical therapy provided by the Developmental Disabilities program at Sheltering Arms within the one month prior to the baseline assessment
- Lives within the community in their own home or group housing
You may not qualify if:
- GMFCS level IV or V
- Unable to follow two-step directions
- Adults who have a medical or legal power of attorney who sign their health authorization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sheltering Arms
Mechanicsville, Virginia, 23116, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacey C Dusing, Ph.D., PT
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blinded to group assignment. It is not possible to blind the participants or the care providers.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2017
First Posted
July 17, 2017
Study Start
July 26, 2017
Primary Completion
December 20, 2018
Study Completion
December 20, 2018
Last Updated
August 7, 2019
Record last verified: 2019-08