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Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke

Primary Purpose

Stroke, Activities of Daily Living

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Approach-Instrumental Activities of Daily Living
Home health education
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Activities of Daily Living, Home Care Services

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardinal Tien Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A-IADL Group

Control group

Arm Description

Approach-Instrumental Activities of Daily Living in home

Home health education

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment
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.
Balance computerized adaptive testing
The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.
Mini Mental State Examination
The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.
Participation Measure-3 Domains ,4 Dimensions
The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.
Canadian Occupational Performance Measure
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.
Barthel Index (BI) -based Supplementary Scales
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.
Frenchay Activities Index
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.
Lawnton Instrumental Activities of Daily Living
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.
Stroke Impact Scale
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.
Stroke Self-Efficacy Questionnaire
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.
Kingston Caregiver Stress Scale
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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2020
Last Updated
July 21, 2021
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04399759
Brief Title
Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke
Official Title
Investigation of the Effect on Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Activities of Daily Living
Keywords
Stroke, Activities of Daily Living, Home Care Services

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-IADL Group
Arm Type
Experimental
Arm Description
Approach-Instrumental Activities of Daily Living in home
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Home health education
Intervention Type
Behavioral
Intervention Name(s)
Approach-Instrumental Activities of Daily Living
Intervention Description
Individualized instrumental activities of daily living training
Intervention Type
Behavioral
Intervention Name(s)
Home health education
Intervention Description
Individualized home health education
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
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.
Time Frame
Baseline to 6 weeks
Title
Balance computerized adaptive testing
Description
The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.
Time Frame
Baseline to 6 weeks
Title
Mini Mental State Examination
Description
The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.
Time Frame
Baseline to 6 weeks
Title
Participation Measure-3 Domains ,4 Dimensions
Description
The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.
Time Frame
Baseline to 6 weeks
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
Baseline to 6 weeks
Title
Barthel Index (BI) -based Supplementary Scales
Description
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.
Time Frame
Baseline to 6 weeks
Title
Frenchay Activities Index
Description
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.
Time Frame
Baseline to 6 weeks
Title
Lawnton Instrumental Activities of Daily Living
Description
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.
Time Frame
Baseline to 6 weeks
Title
Stroke Impact Scale
Description
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.
Time Frame
Baseline to 6 weeks
Title
Stroke Self-Efficacy Questionnaire
Description
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.
Time Frame
Baseline to 6 weeks
Title
Kingston Caregiver Stress Scale
Description
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.
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Chi Chiu, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cardinal Tien Hospital
City
New Taipei City
State/Province
Xindian Dist
ZIP/Postal Code
231403
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35349186
Citation
Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
Results Reference
derived

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Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke

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