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NCT Number: NCT07253506

Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale in Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. The Modified Rankin Scale

    Time frame: Baseline

    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.

  2. Modified Barthel Index

    Time frame: Baseline

    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.

  3. Stroke Impact Scale

    Time frame: Baseline

    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.

  4. Treatment Burden Questionnaire

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale in Stroke Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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