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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03828851
Other study ID # 201712067RIND
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2018
Est. completion date September 20, 2018

Study information

Verified date March 2020
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effects of the Domiciliary care- Activities of Daily Living program on activities of daily living (ADL), motor, cognition, perception, sensory, quality of life, and depression for patients with stroke.


Description:

Administering ADL and recovery of ADL functions are the primary efficacy indicators in long-term care and the main treatment goals in rehabilitation for patients with stroke. Residential rehabilitation is a direct way to observe patients' living environment and provides feasible ADL treatment plans for patients with stroke living at home or in the community. The purpose of this study was to investigate the effects of the Domiciliary care- Activities of Daily Living program on activities of daily living, motor, cognition, perception, sensory, quality of life, and depression. The eligible participants were recruited and assigned into two groups: ADL home program and control group who received traditional rehabilitation in hospital. The primary outcome measures were the Canadian Occupational Performance Measure, the Barthel Index-based Supplementary Scales, the Frenchay Activities Index, and ADL domain of the Stroke Impact Scale. The secondary outcome measures were the Fugl-Meyer Assessment, the Mini Mental State Examination, the Test of Visual Perceptual Skills-Third Edition, and the Center of Epidemiological Study-Depression.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date September 20, 2018
Est. primary completion date September 20, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 99 Years
Eligibility Inclusion Criteria: - Diagnosis of stroke - Aged > 20 years - Score 2-4 of the modified Rankin Scale - Capability of following instructions - Willing to participants to the study Exclusion Criteria: - Diagnoses of dementia and Parkinson's disease - Physical limitations because of orthopedics diseases - Peripheral nerve injury

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Domiciliary care - Activities of Daily Living
Home-based ADL training.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei Zhongzheng District

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of the Canadian Occupational Performance Measure The Canadian Occupational Performance Measure assesses occupational performance. The total score ranges from 1-10. A higher score indicates better occupational performance. Changes of occupational performance will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
Primary Changes of the Barthel Index-based Supplementary Scales The Barthel Index-based Supplementary Scales assesses basic activities of daily living. The total score range from 0-58. A higher score indicates better basic activities of daily living. Changes of basic activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
Primary Changes of the Frenchay Activities Index The Frenchay Activities Index assesses instrumental activities of daily living. The total score range from 0-45. A higher score indicates better instrumental activities of daily living. Changes of instrumental activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
Primary Changes of the ADL domain of the Stroke Impact Scale The ADL domain of the Stroke Impact Scale assess difficulty in performing activities of daily living. The domain score range from 10-50. A higher score indicates less difficulty in performing activities of daily living. Changes of difficulty in performing activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
Secondary Changes of the Fugl-Meyer Assessment The Fugl-Meyer Assessment assesses ability of motor control. The total score range from 0-226. A higher score indicates better ability of motor control. Changes of ability of motor control will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
Secondary Changes of the Mini Mental State Examination The Mini Mental State Examination assesses general cognitive ability. The total score range from 0-30. A higher score indicates better general cognitive ability. Changes of general cognitive ability will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
Secondary Changes of the Test of Visual Perceptual Skills-Third Edition The Test of Visual Perceptual Skills-Third Edition assesses visual perception. The total score range from 0-112. A higher score indicates better visual perception. Changes of visual perception will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
Secondary Changes of the Center of Epidemiological Study-Depression The Center of Epidemiological Study-Depression assesses depression conditions. The total score range from 0-60. A higher score indicates more serious depression conditions. Changes of depression conditions will be assessed at the 6 weeks, 12 weeks, and 6 months. 6 months
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