A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients

Study Overview
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Brief Summary
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To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.

Detailed Description
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In the hospital, most rehabilitation units are like sheltered workshops and the therapists work with stroke patients in well-designed, but non-home-like, environment to improve the stroke patient's functional ability. After returning home, stroke patients face new challenges and also need to assume more responsibility for daily activities. Without continuing rehabilitation training or proper support, the patients can easily fall into a sedentary lifestyle and lead to declines in functional ability.However, providing home-based exercise by therapists directly would increase the health care cost and may not be practical for chronic stroke patients. Hence, the objective of the present study was to determine whether a caregiver-mediated, home-based intervention program is effective for improving stroke patients' functional ability and social participation.

Official Title
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Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Other: Care-giver mediated training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V) No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities) Exclusion Criteria: Recurring strokes Mental or cognitive impairment Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction) Caregiver with mental/behavioral disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Care-giver mediated training<br>Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need. | Other: Care-giver mediated training<br>* A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.<br>|
| No Intervention: Standard-care<br>Maintain the inherent standard-care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale | Change from baseline in Stroke Impact Scale at 12 weeks | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter walking speed | Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks | Baseline and 12 weeks | 
| Berg balance scale | Change from baseline in berg balance scale score at 12 weeks | Baseline and 12 weeks | 
| 6-min walking distance | Change from baseline in 6-min walking distance at 12 weeks | Baseline and 12 weeks | 
| Bathel index score | Change from baseline in Bathel index score at 12 weeks | Baseline and 12 weeks | 
| Lawton Instrumental Activities of Daily Living scale (IADL) | Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks | Baseline and 12 weeks | 
| Fugl-Meyer Assessment Scale | Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic stroke patients, Stroke rehabilitation, Caregiver, Caregiver-mediated intervention