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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693341
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : March 29, 2013
National Science Council, Taiwan
Information provided by (Responsible Party):
Alan C. Tsai, Ph. D., Asia University

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

Condition or disease Intervention/treatment Phase
Stroke Other: Care-giver mediated training Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Caregiver-mediated Intervention in Home-living Chronic Stroke Patients
Study Start Date : October 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Active Comparator: Care-giver mediated training
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
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.

No Intervention: Standard-care
Maintain the inherent standard-care

Primary Outcome Measures :
  1. Stroke Impact Scale [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in Stroke Impact Scale at 12 weeks

Secondary Outcome Measures :
  1. 10-meter walking speed [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks

  2. Berg balance scale [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in berg balance scale score at 12 weeks

  3. 6-min walking distance [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in 6-min walking distance at 12 weeks

  4. Bathel index score [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in Bathel index score at 12 weeks

  5. Lawton Instrumental Activities of Daily Living scale (IADL) [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks

  6. Fugl-Meyer Assessment Scale [ Time Frame: Baseline and 12 weeks ]
    Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks

Other Outcome Measures:
  1. Center for Epidemiologic Studies Depression Scale [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks

  2. Caregiver Burden Scale [ Time Frame: baseline and 12 weeks ]
    Change from baseline in Caregiver Burden Scale at 12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
  2. No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)

Exclusion Criteria:

  1. Recurring strokes
  2. Mental or cognitive impairment
  3. Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
  4. Caregiver with mental/behavioral disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693341

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St. Joseph Hospital
Kaohsiung, Taiwan, 80288
Sponsors and Collaborators
Asia University
National Science Council, Taiwan
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Study Chair: Alan. C Tsai, PhD Asia University

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Responsible Party: Alan C. Tsai, Ph. D., Professor, Asia University Identifier: NCT01693341    
Other Study ID Numbers: CT-tsaiac1943
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Alan C. Tsai, Ph. D., Asia University:
Chronic stroke patients
Stroke rehabilitation
Caregiver-mediated intervention
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases