Clinical trial NCT01693341: A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients
Official title: Caregiver-mediated Intervention in Home-living Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Chronic stroke patients
Stroke rehabilitation
Caregiver
Caregiver-mediated intervention
Lead sponsor: Asia University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Stroke Impact Scale
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: 10-meter walking speed
timeFrame: Baseline and 12 weeks
measure: Berg balance scale
timeFrame: Baseline and 12 weeks
measure: 6-min walking distance
timeFrame: Baseline and 12 weeks
measure: Bathel index score
timeFrame: Baseline and 12 weeks
measure: Lawton Instrumental Activities of Daily Living scale (IADL)
timeFrame: Baseline and 12 weeks
measure: Fugl-Meyer Assessment Scale
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline and 12 weeks
measure: Caregiver Burden Scale
timeFrame: baseline and 12 weeks
Locations:
city: Kaohsiung
country: Taiwan
facility: St. Joseph Hospital
Study officials:
affiliation: Asia University
name: Alan. C Tsai, PhD
role: STUDY_CHAIR
References:
citation: 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.