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Clinical Trials/NCT01693341
NCT01693341CompletedNot Applicable

Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

Asia University1 site in 1 country50 target enrollmentStarted: October 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Stroke Impact Scale

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Care-giver mediated training

Active Comparator

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: Care-giver mediated training (Other)

Standard-care

No Intervention

Maintain the inherent standard-care

Outcomes

Primary Outcomes

Stroke Impact Scale

Time Frame: Baseline and 12 weeks

Change from baseline in Stroke Impact Scale at 12 weeks

Secondary Outcomes

  • 10-meter walking speed(Baseline and 12 weeks)
  • Lawton Instrumental Activities of Daily Living scale (IADL)(Baseline and 12 weeks)
  • Berg balance scale(Baseline and 12 weeks)
  • 6-min walking distance(Baseline and 12 weeks)
  • Bathel index score(Baseline and 12 weeks)
  • Fugl-Meyer Assessment Scale(Baseline and 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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