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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399759
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
En Chi, Chiu, National Taipei University of Nursing and Health Sciences

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.

Condition or disease Intervention/treatment Phase
Stroke Activities of Daily Living Behavioral: Approach-Instrumental Activities of Daily Living Behavioral: Home rehabilitation Not Applicable

Detailed Description:
Subjects will be randomized to intervention group and control group. The experiment is designed as randomized cross-over control trial. The primary outcome included 10 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 and Stroke Self-Efficacy Questionnaire.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Effect on Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke
Actual Study Start Date : January 19, 2020
Estimated Primary Completion Date : January 18, 2021
Estimated Study Completion Date : January 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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 rehabilitation
Behavioral: Home rehabilitation
General home rehabilitation no individualized




Primary Outcome Measures :
  1. Fugl-Meyer Assessment [ Time Frame: Baseline to 6 weeks ]
    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.

  2. Balance computerized adaptive testing [ Time Frame: Baseline to 6 weeks ]
    Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.

  3. Mini Mental State Examination (MMSE) [ Time Frame: Baseline to 6 weeks ]
    Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.

  4. Participation Measure-3 Domains ,4 Dimensions (PM-3D4D) [ Time Frame: Baseline to 6 weeks ]
    Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.

  5. Canadian Occupational Performance Measure (COPM) [ 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.

  6. Barthel Index (BI) -based Supplementary Scales [ Time Frame: Baseline to 6 weeks ]
    Barthel Index-based Supplementary Scales assesses functional activities of daily living. The score ranges is 0 to 100. A higher score indicates better functional activities of daily living.

  7. Frenchay Activities Index (FAI) [ 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 functional activities of daily living.

  8. The Lawton Instrumental Activities of Daily Living [ Time Frame: Baseline to 6 weeks ]
    Lawnton Instrumental Activities of Daily Living assesses functional activities of daily living.The score ranges is 0 to 64. A higher score indicates better functional activities of daily living.

  9. Stroke Impact Scale (SIS) [ 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.

  10. Stroke Self-Efficacy Questionnaire (SSEQ) [ Time Frame: Baseline to 6 weeks ]
    The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judge- ments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy.



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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399759


Contacts
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Contact: Chiu En-Chi, PhD +886-2-28227101 ext 6206 enchichiu@ntunhs.edu.tw

Locations
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Taiwan
Cardinal Tien Hospital Recruiting
New Taipei City, Xindian Dist, Taiwan, 231403
Contact: Chiu En-Chi, PhD    +886-2-28227101 ext 6206    enchichiu@ntunhs.edu.tw   
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences
Investigators
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Study Director: Chiu En-Chi, PhD National Taipei University of Nursing and Health Sciences
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Responsible Party: En Chi, Chiu, Associate Professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier: NCT04399759    
Other Study ID Numbers: CTH-108-2-5-029
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by En Chi, Chiu, National Taipei University of Nursing and Health Sciences:
Stroke
Activities of Daily Living
Home Care Services
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases