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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Temporal Adaptation Approach
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, human activities, participation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kutahya Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Used Temporal Adaptation Approach

Follow up via telephone calls

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT06085469
Brief Title
Investigation of the Effects of Temporal Adaptation Approach in Post-Discharge Stroke Individuals
Official Title
Investigation of the Effects of Temporal Adaptation Approach in Post-Discharge Stroke Individuals: A Randomized Controlled Study With One Month Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, human activities, participation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Used Temporal Adaptation Approach
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Follow up via telephone calls
Intervention Type
Behavioral
Intervention Name(s)
Temporal Adaptation Approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
The Canadian Occupational Performance Measure is client-defined; and consists of both a performance (objective) and a satisfaction (subjective) dimension.
Time Frame
30 minutes
Title
Occupational Balance Questionnaire
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Modified Occupational Questionnaire
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İbrahim Y. TATLI, PhD
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kutahya Health Sciences University
City
Kütahya
ZIP/Postal Code
43020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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