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CompletedNCT04399759Updated Jul 28, 2021

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

An interventional study of Approach-Instrumental Activities of Daily Living and Home health education in Stroke and Activities of Daily Living, sponsored by National Taipei University of Nursing and Health Sciences. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
20 Years to 99 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Stroke
  • Activities of Daily Living

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Keywords

  • Stroke
  • Activities of Daily Living
  • Home Care Services
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 27 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

National Taipei University of Nursing and Health Sciences is the lead sponsor of 119 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Diagnosis of dementia
  • History of orthopedic diseases or peripheral nerve injury
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    A-IADL Group

    Approach-Instrumental Activities of Daily Living in home

    Behavioral: Approach-Instrumental Activities of Daily Living

  • Active comparator
    Control group

    Home health education

    Behavioral: Home health education

Interventions

  • BehavioralApproach-Instrumental Activities of Daily Living

    Individualized instrumental activities of daily living training

  • BehavioralHome health education

    Individualized home health education

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 6 weeks

  2. Balance computerized adaptive testing

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

    Time frame: Baseline to 6 weeks

  3. 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.

    Time frame: Baseline to 6 weeks

  4. Participation Measure-3 Domains ,4 Dimensions

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

    Time frame: Baseline to 6 weeks

  5. 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.

    Time frame: Baseline to 6 weeks

  6. 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.

    Time frame: Baseline to 6 weeks

  7. 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.

    Time frame: Baseline to 6 weeks

  8. 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.

    Time frame: Baseline to 6 weeks

  9. 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.

    Time frame: Baseline to 6 weeks

  10. 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.

    Time frame: Baseline to 6 weeks

  11. 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.

    Time frame: Baseline to 6 weeks

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Study locations

1 site
  • Cardinal Tien Hospital
    New Taipei City, Xindian Dist 231403, Taiwan
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References and documents

Publications

  • 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. PubMed 35349186 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04399759
Lead sponsor
National Taipei University of Nursing and Health Sciences
Responsible party
En-Chi Chiu (Associate Professor, National Taipei University of Nursing and Health Sciences) — Principal investigator
First posted
May 22, 2020
Start date
Sep 4, 2020
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021
Last update
Jul 28, 2021

Study contacts

En-Chi Chiu, PhD
study director · National Taipei University of Nursing and Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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