Supervised Fitness Program for Adults With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Exercise Group
Fitness Center Group
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Sheltering Arms
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Home Group
Center Group
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change in six-minute walk test (6MWT)
measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Full Information
NCT ID
NCT03218774
First Posted
July 12, 2017
Last Updated
August 5, 2019
Sponsor
Virginia Commonwealth University
Collaborators
Sheltering Arms Physical Rehabilitation Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT03218774
Brief Title
Supervised Fitness Program for Adults With Cerebral Palsy
Official Title
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?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Sheltering Arms Physical Rehabilitation Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The proposed study will address the lifelong need for fitness in adults with cerebral palsy compared to individuals provided with a home exercise program at the end of their individualized physical therapy, individuals in the fitness group will…
Primary Hypothesis:
Have higher Pediatric Evaluation of Disability Inventory Computer Adapted Test (PEDICAT) scores at the +12 weeks post intervention visit
Increase their PEDICAT scores across the study period, while the home fitness group will decrease performance on the PEDICAT.
Complete the Timed Up and Go (TUG) more quickly at +12 weeks post intervention
Secondary Hypothesis (study not powered for these variables):
Walk further on the Six Minute Walk Test (6MWT) at the +12 weeks post intervention visit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to group assignment. It is not possible to blind the participants or the care providers.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Group
Arm Type
Other
Arm Title
Center Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Home Exercise Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fitness Center Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score
Description
The PEDI-CAT assesses function in 4 domains: Daily Activity, Mobility, Social/Cognitive, Responsibility
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Change in Timed Up and Go (TUG) score
Description
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
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in six-minute walk test (6MWT)
Description
measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey C Dusing, Ph.D., PT
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheltering Arms
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
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Supervised Fitness Program for Adults With Cerebral Palsy
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