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Completed

NCT Number: NCT04744324

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

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.

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Key information

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Shihlin District, 111045, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-supporting Care

Behavioral

Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)

Home health education

Behavioral

Individualized home health education

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2021
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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