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临床试验/NCT04399759
NCT04399759已完成不适用

Investigation of the Effect on Instrumental Activities of Daily Living Approach in Home Environment 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 27 人开始时间: 2020年9月4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
27
试验地点
2
主要终点
Lawnton Instrumental Activities of Daily Living

研究概览

简要总结

The purpose of this study was to conduct a randomized clinical trial. Implement instrumental daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of A-IADL on stroke patients' movement, cognition, social participation, daily life function 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 11 measures, Fugl-Meyer Assessment, Balance computerized adaptive testing, Mini Mental State Examination, Participation Measure-3 Domains ,4 Dimensions, Canadian Occupational Performance Measure, Barthel Index-based Supplementary Scales, Frenchay Activities Index, Lawnton Instrumental Activities of Daily Living, stroke impact scale, Stroke Self-Efficacy Questionnaire, and Kingston Caregiver Stress Scale.

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

结局指标

主要结局

Lawnton Instrumental Activities of Daily Living

时间窗: Baseline to 6 weeks

The Lawnton Instrumental Activities of Daily Living assesses instrumental activities of daily living.The score ranges is 0 to 8. A higher score indicates better instrumental activities of daily living.

Balance computerized adaptive testing

时间窗: Baseline to 6 weeks

The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.

Mini Mental State Examination

时间窗: Baseline to 6 weeks

The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.

Canadian Occupational Performance Measure

时间窗: Baseline to 6 weeks

The COPM protocol is divided into 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.

Fugl-Meyer Assessment

时间窗: Baseline to 6 weeks

The Fugl-Meyer Assessment scale is an index 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.

Barthel Index (BI) -based Supplementary Scales

时间窗: Baseline to 6 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.

Stroke Impact Scale

时间窗: Baseline to 6 weeks

The Stroke Impact Scale assesses other dimensions of 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.

Participation Measure-3 Domains ,4 Dimensions

时间窗: Baseline to 6 weeks

The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.

Stroke Self-Efficacy Questionnaire

时间窗: Baseline to 6 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.

Frenchay Activities Index

时间窗: Baseline to 6 weeks

The Frenchay Activities Index is a measure of instrumental activities of daily living for use with patients recovering from stroke. The score ranges is 0 to 45. A higher score indicates better instrumental activities of daily living.

Kingston Caregiver Stress Scale

时间窗: Baseline to 6 weeks

The Kingston Caregiver Stress Scale is a self-report scale measuring caregiver stress. The score ranges is 10 to 50. A higher score indicates greater stress.

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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