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

September 20, 2012
March 28, 2013
October 2011
January 2013   (final data collection date for primary outcome measure)
Stroke Impact Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in Stroke Impact Scale at 12 weeks
Same as current
Complete list of historical versions of study NCT01693341 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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
Same as current
 
A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients
Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Stroke
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.
  • 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.
    Intervention: Other: Care-giver mediated training
  • No Intervention: Standard-care
    Maintain the inherent standard-care
Galvin R, Cusack T, O'Grady E, Murphy TB, Stokes E. Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. Stroke. 2011 Mar;42(3):681-6. doi: 10.1161/STROKEAHA.110.594689. Epub 2011 Jan 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01693341
CT-tsaiac1943
Yes
Alan C. Tsai, Ph. D., Asia University
Asia University
National Science Council, Taiwan
Study Chair: Alan. C Tsai, PhD Asia University
Asia University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP