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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr. Brenda Brouwer, Queen's University
ClinicalTrials.gov Identifier:
NCT00400712
First received: November 16, 2006
Last updated: April 3, 2016
Last verified: April 2016
  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: Parallel 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:
  • Subjective Index of Physical and Social Outcome (SIPSO) [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
    The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration.

  • Subjective Index of Social Integration (Subscale of SIPSO) [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
    see Subjective Index of Physical and Social Outcome (SIPSO) above

  • Subjective Index of Physical Integration (Subscale of SIPSO) [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
    see 'Subjective Index of Physical and Social Outcome (SIPSO) above


Secondary Outcome Measures:
  • Mobility Function [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
    Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)

  • Physical Capacity [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.

  • Health-related Quality of Life - Physical [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
    The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.

  • Health-related Quality of Life - Mental [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
    The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.


Enrollment: 103
Study Start Date: December 2006
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
natural progression post-stroke
Experimental: Intervention
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one 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   (Adult, Senior)
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

Responsible Party: Dr. 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
Results First Received: November 6, 2015
Last Updated: April 3, 2016
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on August 24, 2016