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

Completed

Phase N/A Results

Trial Description

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.

Conditions

Interventions

  • Physical rehabilitation Behavioral
    Intervention Desc: two weeks intensive physical rehabilitation
    ARM 1: Kind: Experimental
    Label: B
    Description: two weeks of goal directed intensive physical rehabilitation therapy at 6 months and 1 year
    ARM 2: Kind: Experimental
    Label: Intervention
    Description: two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure 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
Primary Subjective Index of Physical and Social Outcome (SIPSO) baseline and 1 year No
Primary Subjective Index of Social Integration (Subscale of SIPSO) baseline and one year No
Primary Subjective Index of Physical Integration (Subscale of SIPSO) baseline and one year No
Secondary Health-related Quality of Life - Physical baseline and one year No
Secondary Health-related Quality of Life - Mental baseline and one year No

Sponsors