NCT04399759

Brief Summary

The purpose of this study was to conduct a randomized clinical trial. Implement instrumental daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of A-IADL on stroke patients' movement, cognition, social participation, daily life function and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2020

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

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 4, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

May 19, 2020

Last Update Submit

July 21, 2021

Conditions

Keywords

StrokeActivities of Daily LivingHome Care Services

Outcome Measures

Primary Outcomes (11)

  • Fugl-Meyer Assessment

    The Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.

    Baseline to 6 weeks

  • Balance computerized adaptive testing

    The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.

    Baseline to 6 weeks

  • Mini Mental State Examination

    The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.

    Baseline to 6 weeks

  • Participation Measure-3 Domains ,4 Dimensions

    The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.

    Baseline to 6 weeks

  • Canadian Occupational Performance Measure

    The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10. A higher score indicates better occupational performance.

    Baseline to 6 weeks

  • Barthel Index (BI) -based Supplementary Scales

    The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.

    Baseline to 6 weeks

  • Frenchay Activities Index

    The Frenchay Activities Index is a measure of instrumental activities of daily living for use with patients recovering from stroke. The score ranges is 0 to 45. A higher score indicates better instrumental activities of daily living.

    Baseline to 6 weeks

  • Lawnton Instrumental Activities of Daily Living

    The Lawnton Instrumental Activities of Daily Living assesses instrumental activities of daily living.The score ranges is 0 to 8. A higher score indicates better instrumental activities of daily living.

    Baseline to 6 weeks

  • Stroke Impact Scale

    The Stroke Impact Scale assesses other dimensions of health-related quality of life: emotion, communication, memory and thinking, and social role function.The score ranges is 59 to 295. A lower score indicates the quality of life less affected by stroke.

    Baseline to 6 weeks

  • Stroke Self-Efficacy Questionnaire

    The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judgments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy.

    Baseline to 6 weeks

  • Kingston Caregiver Stress Scale

    The Kingston Caregiver Stress Scale is a self-report scale measuring caregiver stress. The score ranges is 10 to 50. A higher score indicates greater stress.

    Baseline to 6 weeks

Study Arms (2)

A-IADL Group

EXPERIMENTAL

Approach-Instrumental Activities of Daily Living in home

Behavioral: Approach-Instrumental Activities of Daily Living

Control group

ACTIVE COMPARATOR

Home health education

Behavioral: Home health education

Interventions

Individualized instrumental activities of daily living training

A-IADL Group

Individualized home health education

Control group

Eligibility Criteria

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

You may qualify if:

  • age \> 20 years
  • Diagnosis of stroke
  • The modified Rankin Scale : 2\~4
  • Keep sitting for half an hour by himself/herself
  • Follow instructions
  • Willing to sign the subject's consent

You may not qualify if:

  • Diagnosis of dementia
  • History of orthopedic diseases or peripheral nerve injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardinal Tien Hospital

New Taipei City, Xindian Dist, 231403, 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • En-Chi Chiu, PhD

    National Taipei University of Nursing and Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

September 4, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations