Cerebral PalsyNCT03218774
Supervised Fitness Program for Adults With Cerebral Palsy
A study testing Home Exercise Group and Fitness Center Group in people with Cerebral Palsy, run by Virginia Commonwealth University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Home Exercise Group and Fitness Center Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2017to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sheltering Arms
Mechanicsville, Virginia, 23116
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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?
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.
Read the 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:
- 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
- Conditions
- Cerebral Palsy
- Being tested
- Home Exercise Group, Fitness Center Group
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Group | Other | Not described Receives: Behavioral: Home Exercise Group |
| Center Group | Experimental | Not described Receives: Behavioral: Fitness Center Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (1)
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
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start26 Jul 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheltering Arms Physical Rehabilitation Hospitals
- Responsible party
- Sponsor
- Investigators
- Stacey C Dusing, Ph.D., PT, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218774
- Sponsor's protocol ID
- HM20009344
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03218774
- Acronym / sponsor ID
- HM20009344
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Sheltering Arms Physical Rehabilitation Hospitals
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Group | Other | Behavioral: Home Exercise Group |
| Center Group | Experimental | Behavioral: Fitness Center Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Exercise GroupThe 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. | Behavioural | Home Group |
| Fitness Center GroupThe 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. | Behavioural | Center Group |
Primary outcome
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
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
1 secondary outcome
Change in six-minute walk test (6MWT)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey C Dusing, Ph.D., PT principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Group and Fitness Center Group in people with Cerebral Palsy, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.