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

Stroke Clinical Trial

Official title:

Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00400712
• Other study ID #: HS SRA 5974
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2006
• Last updated: September 19, 2011
• Start date: December 2006
• Est. completion date: November 2011

Study information

• Verified date: September 2011
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• physical rehabilitation
two weeks intensive physical rehabilitation

Locations

Country	Name	City	State
Canada	Queen's University School of Rehabilitation Therapy	Kingston	Ontario
Canada	School of Physical Therapy, University of Western Ontario	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	community participation and reintegration		baseline, 6 months and 1 year	No
Primary	mobility function		baseline, 6 months and 1 year	No
Primary	physical capacity		baseline, 6 months, 12 months	No
Primary	bone integrity		baseline and 1 year	No
Primary	qualitative aspects of recovery		baseline, 3, 6 and 1 year	No
Secondary	Depression		(baseline, 3 month intervals to 15 months)	No
Secondary	Bone geometry		(baseline, 6 and 12 months)	No