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

Stroke Clinical Trial

Official title:

Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693341
• Other study ID #: CT-tsaiac1943
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: March 28, 2013
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: Asia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	St. Joseph Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Asia University	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Center for Epidemiologic Studies Depression Scale	Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks	Baseline and 12 weeks	No
Other	Caregiver Burden Scale	Change from baseline in Caregiver Burden Scale at 12 weeks	baseline and 12 weeks	No
Primary	Stroke Impact Scale	Change from baseline in Stroke Impact Scale at 12 weeks	Baseline and 12 weeks	No
Secondary	10-meter walking speed	Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks	Baseline and 12 weeks	No
Secondary	Berg balance scale	Change from baseline in berg balance scale score at 12 weeks	Baseline and 12 weeks	No
Secondary	6-min walking distance	Change from baseline in 6-min walking distance at 12 weeks	Baseline and 12 weeks	No
Secondary	Bathel index score	Change from baseline in Bathel index score at 12 weeks	Baseline and 12 weeks	No
Secondary	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	No
Secondary	Fugl-Meyer Assessment Scale	Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks	Baseline and 12 weeks	No