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临床试验/NCT04744324
NCT04744324已完成不适用

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

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Barthel Index -based Supplementary Scales

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Diagnosis of dementia
  • History of orthopedic diseases or peripheral nerve injury
  • readmission because of stroke

结局指标

主要结局

Barthel Index -based Supplementary Scales

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

En-Chi Chiu

Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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