- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00400712
Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?
April 3, 2016 updated by: Dr. Brenda Brouwer, Queen's University
Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?
Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation.
There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function.
The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.
Study Overview
Detailed Description
The extent to which impairment (physical capacity) and function influence community reintegration is unclear.
One of the challenges is that physical parameters change over time as does the person's awareness and perception of what activities are important to be able to engage in at the community level.
Interventions have led to gains in physical capacity, function and community reintegration, but the benefits have been shown to dissipate within three to six months.
It has been suggested that maintenance therapy (tune-ups) for stroke survivors post-discharge could prevent or curtail decline in function of aging stroke survivors and enhance quality of life and well being; constructs that relate strongly to community reintegration.
This study will determine whether tune-ups can alter the time course and magnitude of changes in physical capacity and function and their influence on community reintegration.
Stroke survivors discharged from rehabilitation will be followed for a 15 month period with laboratory or home assessments conducted at 3 month intervals.
Assessors will be blind to whether the subject is receiving a tune up.
Evaluations conducted after the tune-up at 9 months and 12 months post-discharge will allow us to determine if the tune-up effectively reduced physical impairment, improved function and resulted in better community reintegration compared to control.
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
- Queen's University School of Rehabilitation Therapy
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London, Ontario, Canada, N6G 1H1
- School of Physical Therapy, University of Western Ontario
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- first major unilateral hemispheric stroke,
- english speaking,
- adequate verbal communication,
- discharged home or residential care
Exclusion Criteria:
- serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
natural progression post-stroke
|
|
Experimental: Intervention
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
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two weeks intensive physical rehabilitation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Index of Physical and Social Outcome (SIPSO)
Time Frame: baseline and 1 year
|
The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation.
Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales).
The total score reflects reintegration.
|
baseline and 1 year
|
Subjective Index of Social Integration (Subscale of SIPSO)
Time Frame: baseline and one year
|
see Subjective Index of Physical and Social Outcome (SIPSO) above
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baseline and one year
|
Subjective Index of Physical Integration (Subscale of SIPSO)
Time Frame: baseline and one year
|
see 'Subjective Index of Physical and Social Outcome (SIPSO) above
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baseline and one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility Function
Time Frame: baseline and 1 year
|
Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)
|
baseline and 1 year
|
Physical Capacity
Time Frame: baseline and 12 months
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6 minute walk test (6MWT).
Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.
|
baseline and 12 months
|
Health-related Quality of Life - Physical
Time Frame: baseline and one year
|
The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health).
The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.
|
baseline and one year
|
Health-related Quality of Life - Mental
Time Frame: baseline and one year
|
The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health).
The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.
|
baseline and one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brenda J Brouwer, PhD, Queen's University
- Principal Investigator: Jayne Garland, Ph.D, Western University, Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brouwer B, Bryant D, Garland SJ. Effectiveness of Client-Centered "Tune-Ups" on Community Reintegration, Mobility, and Quality of Life After Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1325-1332. doi: 10.1016/j.apmr.2017.12.034. Epub 2018 Apr 3.
- Cohen JW, Ivanova TD, Brouwer B, Miller KJ, Bryant D, Garland SJ. Do Performance Measures of Strength, Balance, and Mobility Predict Quality of Life and Community Reintegration After Stroke? Arch Phys Med Rehabil. 2018 Apr;99(4):713-719. doi: 10.1016/j.apmr.2017.12.007. Epub 2018 Jan 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 16, 2006
First Submitted That Met QC Criteria
November 16, 2006
First Posted (Estimate)
November 17, 2006
Study Record Updates
Last Update Posted (Estimate)
May 5, 2016
Last Update Submitted That Met QC Criteria
April 3, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS SRA 5974
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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