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

Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01693341
Enrollment
50
Registered
2012-09-26
Start date
2011-10-31
Completion date
2013-01-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Chronic stroke patients, Stroke rehabilitation, Caregiver, Caregiver-mediated intervention

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.

Interventions

OTHERCare-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.

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
Asia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Stroke Impact ScaleBaseline and 12 weeksChange from baseline in Stroke Impact Scale at 12 weeks

Secondary

MeasureTime frameDescription
Fugl-Meyer Assessment ScaleBaseline and 12 weeksChange frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks
10-meter walking speedBaseline and 12 weeksChange from baseline in 10-meter walking speed (cm/sec) at 12 weeks
Berg balance scaleBaseline and 12 weeksChange from baseline in berg balance scale score at 12 weeks
Bathel index scoreBaseline and 12 weeksChange from baseline in Bathel index score at 12 weeks
Lawton Instrumental Activities of Daily Living scale (IADL)Baseline and 12 weeksChange from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks
6-min walking distanceBaseline and 12 weeksChange from baseline in 6-min walking distance at 12 weeks

Other

MeasureTime frameDescription
Center for Epidemiologic Studies Depression ScaleBaseline and 12 weeksChange from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks
Caregiver Burden Scalebaseline and 12 weeksChange from baseline in Caregiver Burden Scale at 12 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026