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

NCT ID: NCT01693341

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-01-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Care-giver mediated training

Intervention Type: OTHER

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.

Standard-care

Maintain the inherent standard-care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Asia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan. C Tsai, PhD

Role: STUDY_CHAIR

Asia University

Locations

St. Joseph Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 21233462 (View on PubMed)

Other Identifiers

CT-tsaiac1943

Identifier Type: -

Identifier Source: org_study_id