StrokeNCT06085469
Investigation of the Effects of Temporal Adaptation Approach in Post-Discharge Stroke Individuals
A study testing Temporal Adaptation Approach in people with Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Temporal Adaptation Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2020to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43020
About this study
Official title: 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
- Conditions
- Stroke
- Being tested
- Temporal Adaptation Approach
- Keywords
- Rehabilitation, human activities, participation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Adaptation ApproachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Used Temporal Adaptation Approach Receives: Behavioral: Temporal Adaptation Approach |
| Control Group | No intervention | Follow up via telephone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure is client-defined; and consists of both a performance (objective) and a satisfaction (subjective) dimension.
Measured: 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.
Measured: 10 minutes
Secondary outcomes (1)
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start12 Mar 2020
- Primary completion20 Oct 2020
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Yavuz TATLI, Kutahya Health Sciences University
- Investigators
- İbrahim Y. TATLI, PhD, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085469
- Sponsor's protocol ID
- E.11686
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tatli IY, Ekici G, Akel BS, Temizkan E. Temporal adaptation approach in stroke rehabilitation: a randomized controlled one-month follow-up study. Brain Inj. 2026;40(9):783-793. doi: 10.1080/02699052.2026.2675395. Epub 2026 May 20.
PubMed 42159249
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Temporal Adaptation Approach in Post-Discharge Stroke Individuals: A Randomized Controlled Study With One Month Follow-up
- ClinicalTrials.gov ID
- NCT06085469
- Acronym / sponsor ID
- E.11686
- Conditions
- Stroke
- Keywords
- Rehabilitation, human activities, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Temporal Adaptation ApproachUsed Temporal Adaptation Approach |
| Control Group | No intervention | –Follow up via telephone calls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal Adaptation Approachthe 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. | Behavioural | Intervention Group |
Primary outcome
Canadian Occupational Performance Measure
Time frame: 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
Time frame: 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.
1 secondary outcome
Modified Occupational Questionnaire
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 42159249Tatli IY, Ekici G, Akel BS, Temizkan E. Temporal adaptation approach in stroke rehabilitation: a randomized controlled one-month follow-up study. Brain Inj. 2026;40(9):783-793. doi: 10.1080/02699052.2026.2675395. Epub 2026 May 20.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İbrahim Y. TATLI, PhD principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Adaptation Approach in people with Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.