Clinical trial NCT00400712: Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?
Official title: Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: mobility
strength
balance
function
reintegration
community
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2006-11-17
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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)

Primary outcomes:
measure: Subjective Index of Physical and Social Outcome (SIPSO)
timeFrame: baseline and 1 year
measure: Subjective Index of Social Integration (Subscale of SIPSO)
timeFrame: baseline and one year
measure: Subjective Index of Physical Integration (Subscale of SIPSO)
timeFrame: baseline and one year
Secondary outcomes:
measure: Mobility Function
timeFrame: baseline and 1 year
measure: Physical Capacity
timeFrame: baseline and 12 months
measure: Health-related Quality of Life - Physical
timeFrame: baseline and one year
measure: Health-related Quality of Life - Mental
timeFrame: baseline and one year
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University School of Rehabilitation Therapy
state: Ontario
city: London
country: Canada
facility: School of Physical Therapy, University of Western Ontario
state: Ontario
Study officials:
affiliation: Queen's University
name: Brenda J Brouwer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Jayne Garland, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.