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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Care-giver mediated training

• Registration Number: NCT01693341
• Lead Sponsor: Asia University

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care-giver mediated training	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.

Primary Outcome Measures

Name	Time	Method
Stroke Impact Scale	Baseline and 12 weeks	Change from baseline in Stroke Impact Scale at 12 weeks

Secondary Outcome Measures

Name	Time	Method
10-meter walking speed	Baseline and 12 weeks	Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks
Lawton Instrumental Activities of Daily Living scale (IADL)	Baseline and 12 weeks	Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks
6-min walking distance	Baseline and 12 weeks	Change from baseline in 6-min walking distance at 12 weeks
Berg balance scale	Baseline and 12 weeks	Change from baseline in berg balance scale score at 12 weeks
Bathel index score	Baseline and 12 weeks	Change from baseline in Bathel index score at 12 weeks
Fugl-Meyer Assessment Scale	Baseline and 12 weeks	Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks

Trial Locations

Locations (1)

St. Joseph Hospital; 🇨🇳 Kaohsiung, Taiwan