Investigation of the Effects of Temporal Adaptation Approach in Post-Discharge Stroke Individuals

Sponsor

Kutahya Health Sciences University (Other)

Overall Status

Completed

CT.gov ID

NCT06085469

Collaborator

(none)

Enrollment

Location

Arms

40.1

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: Temporal Adaptation Approach	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Investigation of the Effects of Temporal Adaptation Approach in Post-Discharge Stroke Individuals: A Randomized Controlled Study With One Month Follow-up

Actual Study Start Date :

Mar 12, 2020

Actual Primary Completion Date :

Oct 20, 2020

Actual Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Used Temporal Adaptation Approach	Behavioral: Temporal Adaptation Approach 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.
No Intervention: Control Group Follow up via telephone calls

Arm

Intervention/Treatment

Experimental: Intervention Group

Used Temporal Adaptation Approach

Behavioral: Temporal Adaptation Approach

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.

No Intervention: Control Group

Follow up via telephone calls

Outcome Measures

Primary Outcome Measures

Canadian Occupational Performance Measure [30 minutes]
The Canadian Occupational Performance Measure is client-defined; and consists of both a performance (objective) and a satisfaction (subjective) dimension.
Occupational Balance Questionnaire [10 minutes]
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.

Secondary Outcome Measures

Modified Occupational Questionnaire [15 minutes]
The Modified Occupational Questionnaire is a measure of meaningful time use. Basically, the Modified Occupational Questionnaire focuses on two important objectives: what the person was doing or how he/she used their time, and how the person felt about it. The Modified Occupational Questionnaire is a time diary that asks respondents to report on what they do ''on a typical day'' in hour blocks from 05.00 to 05.00 the following day.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The inclusion criteria used for this study are as follows: being in the chronic phase of the stroke disease (˃6 months) and score of ˃26 on the Montreal Cognitive Assessment (MoCA).

Exclusion Criteria:

Exclusion criteria used are as follows: diagnosis of a psychiatric illness strongly affects the participation to daily life activities according to medical reports (such as schizophrenia or bipolar disorder), a physical condition other than stroke that requires medical follow-up (fracture, osteoporosis, etc.) and aphasia that would affect the intervention via interview

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kutahya Health Sciences University	Kütahya		Turkey	43020

Sponsors and Collaborators

Kutahya Health Sciences University

Investigators

Principal Investigator: İbrahim Y. TATLI, PhD, Kutahya Health Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

İbrahim Yavuz TATLI, Assisstant Professor, Kutahya Health Sciences University

ClinicalTrials.gov Identifier:

NCT06085469

Other Study ID Numbers:

E.11686

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by İbrahim Yavuz TATLI, Assisstant Professor, Kutahya Health Sciences University

Rehabilitation, human activities, participation

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Oct 17, 2023