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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Queen's University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Brenda Brouwer, Queen's University
ClinicalTrials.gov Identifier:
NCT00400712
First received: November 16, 2006
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Stroke
Behavioral: physical rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • community participation and reintegration [ Time Frame: baseline, 6 months and 1 year ] [ Designated as safety issue: No ]
  • mobility function [ Time Frame: baseline, 6 months and 1 year ] [ Designated as safety issue: No ]
  • physical capacity [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • bone integrity [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
  • qualitative aspects of recovery [ Time Frame: baseline, 3, 6 and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression [ Time Frame: (baseline, 3 month intervals to 15 months) ] [ Designated as safety issue: No ]
  • Bone geometry [ Time Frame: (baseline, 6 and 12 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: December 2006
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Experimental: B
two weeks of goal directed intensive physical rehabilitation therapy at 6 months and 1 year
Behavioral: physical rehabilitation
two weeks intensive physical rehabilitation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400712

Locations
Canada, Ontario
Queen's University School of Rehabilitation Therapy
Kingston, Ontario, Canada, K7L 3N6
School of Physical Therapy, University of Western Ontario
London, Ontario, Canada, N6G 1H1
Sponsors and Collaborators
Queen's University
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Brenda J Brouwer, PhD Queen's University
Principal Investigator: Jayne Garland, Ph.D University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Brenda Brouwer, Principle investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00400712     History of Changes
Other Study ID Numbers: HS SRA 5974
Study First Received: November 16, 2006
Last Updated: September 19, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
mobility
strength
balance
function
reintegration
community

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014