Supervised Fitness Program for Adults With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Behavioral: Fitness Center Group; Behavioral: Home Exercise Group

• Registration Number: NCT03218774
• Lead Sponsor: Virginia Commonwealth University

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:

1. Have higher Pediatric Evaluation of Disability Inventory Computer Adapted Test (PEDICAT) scores at the +12 weeks post intervention visit

2. Increase their PEDICAT scores across the study period, while the home fitness group will decrease performance on the PEDICAT.

3. Complete the Timed Up and Go (TUG) more quickly at +12 weeks post intervention

Secondary Hypothesis (study not powered for these variables):

4. Walk further on the Six Minute Walk Test (6MWT) at the +12 weeks post intervention visit

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-17
• Study Start: 2017-07-26
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Center Group	Fitness Center Group	-
Home Group	Home Exercise Group	-

Primary Outcome Measures

Name	Time	Method
Change in Timed Up and Go (TUG) score	Baseline, 4 weeks, 8 weeks, 12 weeks	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
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score	Baseline, 4 weeks, 8 weeks, 12 weeks	The PEDI-CAT assesses function in 4 domains: Daily Activity, Mobility, Social/Cognitive, Responsibility

Secondary Outcome Measures

Name	Time	Method
Change in six-minute walk test (6MWT)	Baseline, 4 weeks, 8 weeks, 12 weeks	measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface

Trial Locations

Locations (2)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Sheltering Arms; 🇺🇸 Mechanicsville, Virginia, United States