Overview

This trial is active, not recruiting.

Condition stroke
Treatment physical rehabilitation
Sponsor Queen's University
Collaborator Heart and Stroke Foundation of Ontario
Start date December 2006
End date November 2011
Trial size 108 participants
Trial identifier NCT00400712, HS SRA 5974

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
(Experimental)
two weeks of goal directed intensive physical rehabilitation therapy at 6 months and 1 year
physical rehabilitation
two weeks intensive physical rehabilitation

Primary Outcomes

Measure
community participation and reintegration
time frame: baseline, 6 months and 1 year
mobility function
time frame: baseline, 6 months and 1 year
physical capacity
time frame: baseline, 6 months, 12 months
bone integrity
time frame: baseline and 1 year
qualitative aspects of recovery
time frame: baseline, 3, 6 and 1 year

Secondary Outcomes

Measure
Depression
time frame: (baseline, 3 month intervals to 15 months)
Bone geometry
time frame: (baseline, 6 and 12 months)

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?
Principal investigator Brenda J Brouwer, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Queen's University.