Skip to main content
Clinical Trials/NCT04744324
NCT04744324
Completed
Not Applicable

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

National Taipei University of Nursing and Health Sciences1 site in 1 country28 target enrollmentMarch 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
28
Locations
1
Primary Endpoint
Barthel Index -based Supplementary Scales
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2021
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

En-Chi Chiu

Associate Professor

National Taipei University of Nursing and Health Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

Barthel Index -based Supplementary Scales

Time Frame: Baseline to 4 weeks

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.

Canadian Occupational Performance Measure

Time Frame: Baseline to 4 weeks

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.

Mini Nutritional Assessment

Time Frame: Baseline to 4 weeks

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.

Fugl-Meyer Assessment

Time Frame: Baseline to 4 weeks

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.

Balance computerized adaptive testing

Time Frame: Baseline to 4 weeks

The Balance computerized adaptive testing is to assess balance ability.The score ranges is 0 to 10. A higher score indicates better balance ability.

Mini Mental State Examination-2nd edition

Time Frame: Baseline to 4 weeks

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.

Stroke Impact Scale

Time Frame: Baseline to 4 weeks

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.

Stroke Self-Efficacy Questionnaire

Time Frame: Baseline to 4 weeks

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.

Study Sites (1)

Loading locations...

Similar Trials