Supervised Fitness Program for Adults With Cerebral Palsy

Cerebral Palsy Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218774
• Other study ID #: HM20009344
• Status: Completed
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: August 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sheltering Arms	Mechanicsville	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Sheltering Arms Physical Rehabilitation Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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