NCT03828851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

January 13, 2019

Last Update Submit

March 18, 2021

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Changes of the Fugl-Meyer Assessment

    6 months

  • Changes of the Mini Mental State Examination

    6 months

  • Changes of the Test of Visual Perceptual Skills-Third Edition

    6 months

  • Changes of the Center of Epidemiological Study-Depression

    6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

ADL training program.

Other: Domiciliary care - Activities of Daily Living

Control group

NO INTERVENTION

Receive rehabilitation program in the hospital.

Interventions

Domiciliary care - Activities of Daily LivingOTHER

Home-based ADL training.

Experimental group

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of stroke
  • Aged \> 20 years
  • Score 2-4 of the modified Rankin Scale
  • Capability of following instructions
  • Willing to participants to the study

You may not qualify if:

  • Diagnoses of dementia and Parkinson's disease
  • Physical limitations because of orthopedics diseases
  • Peripheral nerve injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35349186DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Der-Sheng Han, Doctor

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2019

First Posted

February 4, 2019

Study Start

February 15, 2018

Primary Completion

September 20, 2018

Study Completion

September 20, 2018

Last Updated

March 22, 2021

Record last verified: 2020-03

Locations

TW(1)