NCT06085469

Brief Summary

Abstract Introduction: Stroke is a disease that makes it difficult to participate in daily life activities by creating functional losses. Healthy temporal adaptation can increase and support engagement in meaningful activities. This study aims to analyze the effect of the temporal adaptation approach on the post-discharge occupational engagement of individuals with stroke. Methods: This study is a randomized controlled trial with 1 month follow-up. While the TAA approach was applied to the first group, the general condition of the second group was followed during the study. Canadian Occupational Performance Measue was administered to assess occupational performance and satisfaction, and Occupational Balance Questionnaire was for occupational balance. Kewords: Time, stroke, rehabilitation, human activities, participation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2020

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 10, 2023

Last Update Submit

October 10, 2023

Conditions

Keywords

Rehabilitation, human activities, participation

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure

    The Canadian Occupational Performance Measure is client-defined; and consists of both a performance (objective) and a satisfaction (subjective) dimension.

    30 minutes

  • Occupational Balance Questionnaire

    The Occupational Balance Questionnaire is a scale that measures self-rated occupational balance occupational balance in different dimensions. The purpose of the scale is to measure satisfaction according to the amount and variety of daily activities of the individual and to define their occupational balance according to the obtained results.

    10 minutes

Secondary Outcomes (1)

  • Modified Occupational Questionnaire

    15 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Used Temporal Adaptation Approach

Behavioral: Temporal Adaptation Approach

Control Group

NO INTERVENTION

Follow up via telephone calls

Interventions

the temporal adaptation: It includes giving importance to the use of time, choosing meaningful activities, adjusting the time used during these activities and improving it. Such adaptation serves to improve an individual's quality of life, health, and occupational participation.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • İbrahim Y. TATLI, PhD

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 17, 2023

Study Start

March 12, 2020

Primary Completion

October 20, 2020

Study Completion

July 15, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations