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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399759
• Other study ID #: CTH-108-2-5-029
• Status: Completed
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: July 2021
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Stroke

Intervention

Behavioral:
• Approach-Instrumental Activities of Daily Living
Individualized instrumental activities of daily living training
• Home health education
Individualized home health education

Locations

Country	Name	City	State
Taiwan	Cardinal Tien Hospital	New Taipei City	Xindian Dist

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 6 weeks
Primary	Balance computerized adaptive testing	The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks
Primary	Participation Measure-3 Domains ,4 Dimensions	The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks
Primary	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.	Baseline to 6 weeks