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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Alan C. Tsai, Ph. D., Asia University
ClinicalTrials.gov Identifier:
NCT01693341
First received: September 20, 2012
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Stroke
Other: Care-giver mediated training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

Resource links provided by NLM:


Further study details as provided by Asia University:

Primary Outcome Measures:
  • Stroke Impact Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Stroke Impact Scale at 12 weeks


Secondary Outcome Measures:
  • 10-meter walking speed [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks

  • Berg balance scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in berg balance scale score at 12 weeks

  • 6-min walking distance [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in 6-min walking distance at 12 weeks

  • Bathel index score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Bathel index score at 12 weeks

  • Lawton Instrumental Activities of Daily Living scale (IADL) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks

  • Fugl-Meyer Assessment Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks


Other Outcome Measures:
  • Center for Epidemiologic Studies Depression Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks

  • Caregiver Burden Scale [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Caregiver Burden Scale at 12 weeks


Enrollment: 50
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01693341

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

Publications:
Responsible Party: Alan C. Tsai, Ph. D., Professor, Asia University
ClinicalTrials.gov Identifier: NCT01693341     History of Changes
Other Study ID Numbers: CT-tsaiac1943
Study First Received: September 20, 2012
Last Updated: March 28, 2013
Health Authority: Taiwan: Research Ethics Committee

Keywords provided by Asia University:
Chronic stroke patients
Stroke rehabilitation
Caregiver
Caregiver-mediated intervention

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

ClinicalTrials.gov processed this record on July 23, 2014