Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?

NCT ID: NCT00400712

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2012-01-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

natural progression post-stroke

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)

Group Type: EXPERIMENTAL

physical rehabilitation

Intervention Type: BEHAVIORAL

two weeks intensive physical rehabilitation

Interventions

physical rehabilitation

two weeks intensive physical rehabilitation

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Brenda Brouwer

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brenda J Brouwer, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Jayne Garland, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

Queen's University School of Rehabilitation Therapy

Kingston, Ontario, Canada

School of Physical Therapy, University of Western Ontario

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29412167 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29317222 (View on PubMed)

Other Identifiers

HS SRA 5974

Identifier Type: -

Identifier Source: org_study_id