Self-supporting Care Model in Home Environment for Patients With Stroke

Study Overview
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Brief Summary
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The purpose of this study was to administer intervention based on self-supporting care model in home environment and to explore the effects of this intervention on stroke patients' activities of daily living, movement, cognition, nutritional status, and quality of life.

Detailed Description
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Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 8 measures: Barthel Index-based Supplementary Scales, Canadian Occupational Performance Measure, Fugl-Meyer Assessment, Balance Computerized Adaptive Testing, Mini Mental State Examination-2nd edition, Mini Nutritional Assessment, Stroke Impact Scale, and Stroke Self-Efficacy Questionnaire.

Official Title
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Effects of Self-supporting Care Model on Activities of Daily Living for Patients With Stroke

Conditions
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Stroke, Activities of Daily Living

Intervention / Treatment
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* Behavioral: Self-supporting Care
* Behavioral: Home health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 20 years Diagnosis of stroke The modified Rankin Scale : 2 4 Keep sitting for half an hour by himself/herself Follow instructions Willing to sign the subject's consent Exclusion Criteria: Diagnosis of dementia History of orthopedic diseases or peripheral nerve injury readmission because of stroke

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-supporting Care Group<br>Self-supporting Care in home | Behavioral: Self-supporting Care<br>* Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)<br>|
| Active Comparator: Control group<br>Home Health Education | Behavioral: Home health education<br>* Individualized home health education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index -based Supplementary Scales | The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living. | Baseline to 4 weeks | 
| Canadian Occupational Performance Measure | The Canadian Occupational Performance Measure is to measure occupational performance though three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10. A higher score indicates better occupational performance. | Baseline to 4 weeks | 
| Fugl-Meyer Assessment | The Fugl-Meyer Assessment scale is to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function. | Baseline to 4 weeks | 
| Balance computerized adaptive testing | The Balance computerized adaptive testing is to assess balance ability.The score ranges is 0 to 10. A higher score indicates better balance ability. | Baseline to 4 weeks | 
| Mini Mental State Examination-2nd edition | The Mini Mental State Examination-2nd edition is to assess cognitive functions. The score ranges is 0 to 90. A higher score indicates better cognitive functions. | Baseline to 4 weeks | 
| Mini Nutritional Assessment | The Mini Nutritional Assessment is a comprehensive nutritional assessment scale. The score range is 0 to 30 points. The higher the score, the lower the risk of malnutrition. | Baseline to 4 weeks | 
| Stroke Impact Scale | The Stroke Impact Scale is to assess health-related quality of life: emotion, communication, memory and thinking, and social role function. The score ranges is 59 to 295. A lower score indicates the quality of life less affected by stroke. | Baseline to 4 weeks | 
| Stroke Self-Efficacy Questionnaire | The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judgments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy. | Baseline to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Self-supporting Care Model, Home Care Services