StrokeNCT07253506
Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale in Stroke
An observational study of Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will include individuals aged 18-80 years who have been clinically diagnosed with stroke and have spent at least one month at home after discharge. Sociodemographic and clinical characteristics will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 10 Apr 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical diagnosis of stroke (ischemic or hemorrhagic).
Who may be able to join
- Clinical diagnosis of stroke (ischemic or hemorrhagic).
- Having spent at least 1 month at home after hospital discharge (to capture post-acute home care/rehabilitation burden).
- Community-dwelling individuals aged 18-80 years.
- Adequate Turkish reading-writing and communication ability.
- Ability to provide informed consent.
- In cases of mild aphasia, ability to complete the questionnaire independently or with support.
Who cannot join
- History of subarachnoid hemorrhage.
- Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
- Terminal illness (life expectancy < 6 months).
- Inability to complete the questionnaire reliably due to a psychiatric disorder.
- Acute phase (those hospitalized or before discharge).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale in Stroke Patients
This study will include individuals aged 18-80 years who have been clinically diagnosed with stroke and have spent at least one month at home after discharge. Sociodemographic and clinical characteristics will be recorded. Functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index. Ambulation status will be documented with the Holden Scale.
The scale will first be translated into Turkish and then back-translated into English by a bilingual expert whose native language is English. The Turkish version of the scale will be administered to patients. Two independent evaluators will apply the scale twice, one week apart.
Validity will be examined by analyzing the relationship between the scale and the Stroke Impact Scale and the Treatment Burden Questionnaire
- Conditions
- Stroke
- Being tested
- no intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
PETS-Stroke scale
The primary measure, the PETS-Stroke scale, evaluates patients' experiences with treatment and self-management; its scoring system is based on subscale scores typically transformed to 0-100, with higher values reflecting greater perceived burden or difficulty in treatment and self-management.
Measured: Baseline
Secondary outcomes (4)
The Modified Rankin Scale
The Modified Rankin Scale will be used to assess overall functional status; this scale measures global disability on a 0-6 range, with higher scores indicating greater dependence.
Measured: Baseline
Modified Barthel Index
Independence in activities of daily living will be assessed with the Modified Barthel Index, scored between 0 and 100, where higher scores reflect greater functional independence.
Measured: Baseline
Stroke Impact Scale
To assess construct validity, the Stroke Impact Scale will be used; it measures the impact of stroke on domains such as daily activities, mobility, hand function, communication, emotion, memory, and participation, with domain scores transformed to a 0-100 scale in which higher scores represent better status.
Measured: Baseline
Treatment Burden Questionnaire
Treatment burden will be evaluated with the Treatment Burden Questionnaire, where items are scored from 0 to 10, and higher scores indicate greater perceived treatment burden.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253506
- Sponsor's protocol ID
- istftrrr
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale in Stroke Patients
- ClinicalTrials.gov ID
- NCT07253506
- Acronym / sponsor ID
- istftrrr
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 28 Nov 2025 (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.
This study will include individuals aged 18-80 years who have been clinically diagnosed with stroke and have spent at least one month at home after discharge. Sociodemographic and clinical characteristics will be recorded. Functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index. Ambulation status will be documented with the Holden Scale.
The scale will first be translated into Turkish and then back-translated into English by a bilingual expert whose native language is English. The Turkish version of the scale will be administered to patients. Two independent evaluators will apply the scale twice, one week apart.
Validity will be examined by analyzing the relationship between the scale and the Stroke Impact Scale and the Treatment Burden Questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis of stroke (ischemic or hemorrhagic).
Key inclusion criteria (6 listed)
- Clinical diagnosis of stroke (ischemic or hemorrhagic).
- Having spent at least 1 month at home after hospital discharge (to capture post-acute home care/rehabilitation burden).
- Community-dwelling individuals aged 18-80 years.
- Adequate Turkish reading-writing and communication ability.
- Ability to provide informed consent.
Key exclusion criteria (5 listed)
- History of subarachnoid hemorrhage.
- Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
- Terminal illness (life expectancy < 6 months).
- Inability to complete the questionnaire reliably due to a psychiatric disorder.
- Acute phase (those hospitalized or before discharge).
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
PETS-Stroke scale
Time frame: Baseline
The primary measure, the PETS-Stroke scale, evaluates patients' experiences with treatment and self-management; its scoring system is based on subscale scores typically transformed to 0-100, with higher values reflecting greater perceived burden or difficulty in treatment and self-management.
4 secondary outcomes
The Modified Rankin Scale
Time frame: Baseline
Modified Barthel Index
Time frame: Baseline
Stroke Impact Scale
Time frame: Baseline
Treatment Burden Questionnaire
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
PETS-Stroke scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.