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

July 21, 2021 updated by: En-Chi Chiu, National Taipei University of Nursing and Health Sciences

Investigation of the Effect on Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Xindian Dist
      • New Taipei City, Xindian Dist, Taiwan, 231403
        • Cardinal Tien Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A-IADL Group
Approach-Instrumental Activities of Daily Living in home
Behavioral: Approach-Instrumental Activities of Daily Living
Individualized instrumental activities of daily living training
Active Comparator: Control group
Home health education
Behavioral: Home health education
Individualized home health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Investigators

  • Study Director: En-Chi Chiu, PhD, National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2020

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTH-108-2-5-029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Approach-Instrumental Activities of Daily Living

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe