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Clinical Trials/NCT04399759
NCT04399759
Completed
Not Applicable

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 Sciences1 site in 1 country27 target enrollmentSeptember 4, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
27
Locations
1
Primary Endpoint
Lawnton Instrumental Activities of Daily Living
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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 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.

Registry
clinicaltrials.gov
Start Date
September 4, 2020
End Date
April 1, 2021
Last Updated
4 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

Outcomes

Primary Outcomes

Lawnton Instrumental Activities of Daily Living

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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