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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Care-giver mediated training

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 80288
    • St. Joseph Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Standard-care; Maintain the inherent standard-care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale	Change from baseline in Stroke Impact Scale at 12 weeks	Baseline and 12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiologic Studies Depression Scale	Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks	Baseline and 12 weeks
Caregiver Burden Scale	Change from baseline in Caregiver Burden Scale at 12 weeks	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Asia University
• Collaborators: National Science Council, Taiwan
• Investigators: Study Chair: Alan. C Tsai, PhD, Asia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimated): September 26, 2012

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Caregiver; Stroke rehabilitation; Chronic stroke patients; Caregiver-mediated intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CT-tsaiac1943