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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04399759
Collaborator
(none)
27
1
2
6.9
3.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Approach-Instrumental Activities of Daily Living
  • Behavioral: Home health education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (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 :
Sep 4, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment [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.

  2. Balance computerized adaptive testing [Baseline to 6 weeks]

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

  3. Mini Mental State Examination [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.

  4. Participation Measure-3 Domains ,4 Dimensions [Baseline to 6 weeks]

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

  5. Canadian Occupational Performance Measure [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 [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.

  7. Frenchay Activities Index [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.

  8. Lawnton Instrumental Activities of Daily Living [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.

  9. Stroke Impact Scale [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 [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.

  11. Kingston Caregiver Stress Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 99 Years
Sexes Eligible for Study:
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:
  • Diagnosis of dementia

  • History of orthopedic diseases or peripheral nerve injury

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardinal Tien Hospital New Taipei City Xindian Dist Taiwan 231403

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by En-Chi Chiu, Associate Professor, National Taipei University of Nursing and Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2021