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Clinical Trials/NCT03218774
NCT03218774
Completed
Not Applicable

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?

Virginia Commonwealth University2 sites in 1 country18 target enrollmentJuly 26, 2017
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Virginia Commonwealth University
Enrollment
18
Locations
2
Primary Endpoint
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 26, 2017
End Date
December 20, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score

Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks

The PEDI-CAT assesses function in 4 domains: Daily Activity, Mobility, Social/Cognitive, Responsibility

Change in Timed Up and Go (TUG) score

Time Frame: 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

Secondary Outcomes

  • Change in six-minute walk test (6MWT)(Baseline, 4 weeks, 8 weeks, 12 weeks)

Study Sites (2)

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