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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
physical rehabilitation
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring mobility, strength, balance, function, reintegration, community

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Queen's University School of Rehabilitation Therapy
  • School of Physical Therapy, University of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

natural progression post-stroke

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

Outcomes

Primary Outcome Measures

Subjective Index of Physical and Social Outcome (SIPSO)
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)
see Subjective Index of Physical and Social Outcome (SIPSO) above
Subjective Index of Physical Integration (Subscale of SIPSO)
see 'Subjective Index of Physical and Social Outcome (SIPSO) above

Secondary Outcome Measures

Mobility Function
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
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
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
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.

Full Information

First Posted
November 16, 2006
Last Updated
April 3, 2016
Sponsor
Queen's University
Collaborators
Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00400712
Brief Title
Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?
Official Title
Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
mobility, strength, balance, function, reintegration, community

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
natural progression post-stroke
Arm Title
Intervention
Arm Type
Experimental
Arm Description
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
Intervention Type
Behavioral
Intervention Name(s)
physical rehabilitation
Intervention Description
two weeks intensive physical rehabilitation
Primary Outcome Measure Information:
Title
Subjective Index of Physical and Social Outcome (SIPSO)
Description
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.
Time Frame
baseline and 1 year
Title
Subjective Index of Social Integration (Subscale of SIPSO)
Description
see Subjective Index of Physical and Social Outcome (SIPSO) above
Time Frame
baseline and one year
Title
Subjective Index of Physical Integration (Subscale of SIPSO)
Description
see 'Subjective Index of Physical and Social Outcome (SIPSO) above
Time Frame
baseline and one year
Secondary Outcome Measure Information:
Title
Mobility Function
Description
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)
Time Frame
baseline and 1 year
Title
Physical Capacity
Description
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.
Time Frame
baseline and 12 months
Title
Health-related Quality of Life - Physical
Description
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.
Time Frame
baseline and one year
Title
Health-related Quality of Life - Mental
Description
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.
Time Frame
baseline and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda J Brouwer, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jayne Garland, Ph.D
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University School of Rehabilitation Therapy
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
School of Physical Therapy, University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1H1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29412167
Citation
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.
Results Reference
derived
PubMed Identifier
29317222
Citation
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.
Results Reference
derived

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

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