Development of Domiciliary Program on Improving Activities of Daily Living Program for Patients With Stroke

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03828851
Collaborator
(none)
26
1
2
7.1
3.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Domiciliary care - Activities of Daily Living
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Development of Domiciliary Program on Improving Activities of Daily Living Program for Patients With Stroke
Actual Study Start Date :
Feb 15, 2018
Actual Primary Completion Date :
Sep 20, 2018
Actual Study Completion Date :
Sep 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

ADL training program.

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

No Intervention: Control group

Receive rehabilitation program in the hospital.

Outcome Measures

Primary Outcome Measures

  1. Changes of the Canadian Occupational Performance Measure [6 months]

    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.

  2. Changes of the Barthel Index-based Supplementary Scales [6 months]

    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.

  3. Changes of the Frenchay Activities Index [6 months]

    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.

  4. Changes of the ADL domain of the Stroke Impact Scale [6 months]

    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.

Secondary Outcome Measures

  1. Changes of the Fugl-Meyer Assessment [6 months]

    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.

  2. Changes of the Mini Mental State Examination [6 months]

    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.

  3. Changes of the Test of Visual Perceptual Skills-Third Edition [6 months]

    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.

  4. Changes of the Center of Epidemiological Study-Depression [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Zhongzheng District Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Study Chair: Der-Sheng Han, Doctor, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03828851
Other Study ID Numbers:
  • 201712067RIND
First Posted:
Feb 4, 2019
Last Update Posted:
Mar 22, 2021
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2021