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Trial record 23 of 162 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Supervised Fitness Program for Adults With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03218774
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
Sheltering Arms Physical Rehabilitation Hospitals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Behavioral: Home Exercise Group Behavioral: Fitness Center Group Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blinded to group assignment. It is not possible to blind the participants or the care providers.
Primary Purpose: Treatment
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?
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218774


Contacts
Contact: Stacey C Dusing, Ph.D., PT (804) 828-0234 scdusing@vcu.edu

Locations
United States, Virginia
Sheltering Arms Recruiting
Mechanicsville, Virginia, United States, 23116
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Sheltering Arms Physical Rehabilitation Hospitals
Investigators
Principal Investigator: Stacey C Dusing, Ph.D., PT Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03218774     History of Changes
Other Study ID Numbers: HM20009344
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases