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

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ClinicalTrials.gov Identifier: NCT03828851
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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
Stroke Other: Domiciliary care - Activities of Daily Living Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 15, 2018
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018

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.



Primary Outcome Measures :
  1. Changes of the Canadian Occupational Performance Measure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828851


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng District, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Der-Sheng Han, Doctor National Taiwan University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03828851    
Other Study ID Numbers: 201712067RIND
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases