Supervised Fitness Program for Adults With Cerebral Palsy

NCT ID: NCT03218774

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-26

Study Completion Date

2018-12-20

Brief Summary

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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

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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

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will be blinded to group assignment. It is not possible to blind the participants or the care providers.

Study Groups

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Home Group

Group Type OTHER

Home Exercise Group

Intervention Type 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.

Center Group

Group Type EXPERIMENTAL

Fitness Center Group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheltering Arms Physical Rehabilitation Hospitals

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacey C Dusing, Ph.D., PT

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Sheltering Arms

Mechanicsville, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM20009344

Identifier Type: -

Identifier Source: org_study_id

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