Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke |
Behavioral: physical rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors? |
- community participation and reintegration [ Time Frame: baseline, 6 months and 1 year ] [ Designated as safety issue: No ]
- mobility function [ Time Frame: baseline, 6 months and 1 year ] [ Designated as safety issue: No ]
- physical capacity [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
- bone integrity [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
- qualitative aspects of recovery [ Time Frame: baseline, 3, 6 and 1 year ] [ Designated as safety issue: No ]
- Depression [ Time Frame: (baseline, 3 month intervals to 15 months) ] [ Designated as safety issue: No ]
- Bone geometry [ Time Frame: (baseline, 6 and 12 months) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 108 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: A | |
|
Experimental: B
two weeks of goal directed intensive physical rehabilitation therapy at 6 months and 1 year
|
Behavioral: physical rehabilitation
two weeks intensive physical rehabilitation
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Canada, Ontario | |
| Queen's University School of Rehabilitation Therapy | |
| Kingston, Ontario, Canada, K7L 3N6 | |
| School of Physical Therapy, University of Western Ontario | |
| London, Ontario, Canada, N6G 1H1 | |
| Principal Investigator: | Brenda J Brouwer, PhD | Queen's University |
| Principal Investigator: | Jayne Garland, Ph.D | University of Western Ontario, Canada |
More Information
No publications provided
| Responsible Party: | Brenda Brouwer, Principle investigator, Queen's University |
| ClinicalTrials.gov Identifier: | NCT00400712 History of Changes |
| Other Study ID Numbers: | HS SRA 5974 |
| Study First Received: | November 16, 2006 |
| Last Updated: | September 19, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Queen's University:
|
mobility strength balance |
function reintegration community |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013