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Completed

NCT Number: NCT03218774

Supervised Fitness 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheltering Arms, Mechanicsville, Virginia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Exercise Group

Behavioral

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

Behavioral

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 outcomes

  1. 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

  2. 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

  1. Change in six-minute walk test (6MWT)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Sheltering Arms Physical Rehabilitation Hospitals

Registry information

Official study 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?

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 17, 2017
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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