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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Temporal Adaptation Approach

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kütahya, Turkey, 43020
    • Kutahya Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Occupational Questionnaire	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.	15 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation, human activities, participation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: E.11686

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No