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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Domiciliary care - Activities of Daily Living

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng District
    • Taipei, Zhongzheng District, Taiwan, 100
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 20, 2018

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 201712067RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No