Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?
1 other identifier
interventional
103
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Dec 2006
Longer than P75 for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2006
CompletedFirst Posted
Study publicly available on registry
November 17, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
May 5, 2016
CompletedMay 5, 2016
April 1, 2016
4.9 years
November 16, 2006
November 6, 2015
April 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Subjective Index of Physical and Social Outcome (SIPSO)
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)
see Subjective Index of Physical and Social Outcome (SIPSO) above
baseline and one year
Subjective Index of Physical Integration (Subscale of SIPSO)
see 'Subjective Index of Physical and Social Outcome (SIPSO) above
baseline and one year
Secondary Outcomes (4)
Mobility Function
baseline and 1 year
Physical Capacity
baseline and 12 months
Health-related Quality of Life - Physical
baseline and one year
Health-related Quality of Life - Mental
baseline and one year
Study Arms (2)
Control
NO INTERVENTIONnatural progression post-stroke
Intervention
EXPERIMENTALtwo weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
Interventions
Eligibility Criteria
You may qualify if:
- first major unilateral hemispheric stroke,
- english speaking,
- adequate verbal communication,
- discharged home or residential care
You may not qualify if:
- serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Universitylead
- Heart and Stroke Foundation of Ontariocollaborator
Study Sites (2)
Queen's University School of Rehabilitation Therapy
Kingston, Ontario, K7L 3N6, Canada
School of Physical Therapy, University of Western Ontario
London, Ontario, N6G 1H1, Canada
Related Publications (2)
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.
PMID: 29412167DERIVEDCohen 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.
PMID: 29317222DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brenda Brouwer
- Organization
- Queen's University
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda J Brouwer, PhD
Queen's University
- PRINCIPAL INVESTIGATOR
Jayne Garland, Ph.D
Western University, Canada
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
November 16, 2006
First Posted
November 17, 2006
Study Start
December 1, 2006
Primary Completion
November 1, 2011
Study Completion
January 1, 2012
Last Updated
May 5, 2016
Results First Posted
May 5, 2016
Record last verified: 2016-04