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?

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Home Exercise Group; Behavioral: Fitness Center Group

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
      • Sheltering Arms
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Home Group	Behavioral: Home Exercise Group; 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.
Experimental: Center Group	Behavioral: Fitness Center Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Sheltering Arms Physical Rehabilitation Hospitals
• Investigators: Principal Investigator: Stacey C Dusing, Ph.D., PT, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: HM20009344

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No