Parkinson DiseaseNCT07710625
"Turkish Validity and Reliability of the Heat Sensitivity Scale for Individuals With Parkinson's Disease"
An observational study of Parkinson Disease and Temperature Sensivity, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the validity and reliability of the Turkish version of the Heat Sensitivity Scale in individuals with Parkinson's disease. This cross-sectional methodological study will evaluate the psychometric properties of the scale, including internal consistency, test-retest reliability, and… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Temperature Sensivity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2026to 25 May 2027
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals with clinically diagnosed Parkinson's disease (Hoehn and Yahr stage 1-3), aged between 40 and 85 years, with adequate cognitive function (MMSE ≥ 24). Participants will be recruited from patients attending the Movement Disorders Outpatient Clinic of the Neurology Department. The study population represents ambulatory individuals with mild to moderate disease severity suitable for comprehensive biopsychosocial assessment.
Who may be able to join
- Clinical diagnosis of Parkinson's disease
- Hoehn and Yahr stage 1-3
- Age between 40 and 85 years
- Mini-Mental State Examination score ≥ 24
- Sufficient cognitive and communication ability to complete the assessments
- Attendance at the Movement Disorders Outpatient Clinic of the Neurology Department
- Willingness to participate and provide written informed consent
Who cannot join
- Presence of a major psychiatric disorder, such as major depressive disorder or a psychotic disorder
- Diagnosis of advanced dementia
- Presence of an uncontrolled systemic chronic disease, such as uncontrolled diabetes mellitus or hypertension
- Presence of a severe cardiovascular or respiratory condition
- Presence of an additional orthopedic or neurological condition that may affect assessment performance
- Severe visual or hearing impairment that may interfere with the assessments
- Inability to cooperate adequately during the assessments
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, 1 recruiting
- Recruiting
Acibadem University
Istanbul, Turkey, +90
Nuray ALACA, 05324251290, nuray.alaca@acibadem.edu.tr
About this study
Official title: Cross-Cultural Adaptation and Psychometric Evaluation of the Turkish Version of the Heat Sensitivity Scale in Individuals With Parkinson's Disease
The aim of this study is to examine the validity and reliability of the Turkish version of the Heat Sensitivity Scale in individuals with Parkinson's disease. This cross-sectional methodological study will evaluate the psychometric properties of the scale, including internal consistency, test-retest reliability, and construct validity, in order to provide a valid and reliable tool for assessing temperature sensitivity in Turkish-speaking individuals with Parkinson's disease.
- Conditions
- Parkinson Disease, Temperature Sensivity
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat Sensitivity Scale Total Score
Heat sensitivity will be assessed using the Turkish version of the Heat Sensitivity Scale in individuals with Parkinson's disease. The scale evaluates symptoms related to heat sensitivity and their impact on daily life. The total score ranges from 29 to 116, with higher scores indicating greater heat sensitivity-related problems and therefore a worse outcome. Psychometric properties, including internal consistency, test-retest reliability, and construct validity, will be analyzed.
Measured: Baseline (at the time of questionnaire administration)
Secondary outcomes (1)
Parkinson's Disease Questionnaire-39 (PDQ-39) Total and Subscale Scores
Quality of life will be assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39), a validated self-report measure specific to Parkinson's disease. The questionnaire consists of 39 items across 8 domains, including mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Scores can be transformed to a 0-100 scale, with higher scores indicating worse quality of life. PDQ-39 scores will be used to evaluate the construct validity of the Turkish version of the Temperature Sensitivity Scale.
Measured: Baseline (at the time of questionnaire completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start25 May 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710625
- Sponsor's protocol ID
- 2026-05-220
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation and Psychometric Evaluation of the Turkish Version of the Heat Sensitivity Scale in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07710625
- Acronym / sponsor ID
- 2026-05-220
- Conditions
- Parkinson Disease, Temperature Sensivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 17 Jul 2026 (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.
The aim of this study is to examine the validity and reliability of the Turkish version of the Heat Sensitivity Scale in individuals with Parkinson's disease. This cross-sectional methodological study will evaluate the psychometric properties of the scale, including internal consistency, test-retest reliability, and construct validity, in order to provide a valid and reliable tool for assessing temperature sensitivity in Turkish-speaking individuals with Parkinson's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals with clinically diagnosed Parkinson's disease (Hoehn and Yahr stage 1-3), aged between 40 and 85 years, with adequate cognitive function (MMSE ≥ 24). Participants will be recruited from patients attending the Movement Disorders Outpatient Clinic of the Neurology Department. The study population represents ambulatory individuals with mild to moderate disease severity suitable for comprehensive biopsychosocial assessment.
Key inclusion criteria (7 listed)
- Clinical diagnosis of Parkinson's disease
- Hoehn and Yahr stage 1-3
- Age between 40 and 85 years
- Mini-Mental State Examination score ≥ 24
- Sufficient cognitive and communication ability to complete the assessments
Key exclusion criteria (7 listed)
- Presence of a major psychiatric disorder, such as major depressive disorder or a psychotic disorder
- Diagnosis of advanced dementia
- Presence of an uncontrolled systemic chronic disease, such as uncontrolled diabetes mellitus or hypertension
- Presence of a severe cardiovascular or respiratory condition
- Presence of an additional orthopedic or neurological condition that may affect assessment performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heat Sensitivity Scale Total Score
Time frame: Baseline (at the time of questionnaire administration)
Heat sensitivity will be assessed using the Turkish version of the Heat Sensitivity Scale in individuals with Parkinson's disease. The scale evaluates symptoms related to heat sensitivity and their impact on daily life. The total score ranges from 29 to 116, with higher scores indicating greater heat sensitivity-related problems and therefore a worse outcome. Psychometric properties, including internal consistency, test-retest reliability, and construct validity, will be analyzed.
1 secondary outcome
Parkinson's Disease Questionnaire-39 (PDQ-39) Total and Subscale Scores
Time frame: Baseline (at the time of questionnaire completion)
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 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Parkinson Disease and Temperature Sensivity, run by Acibadem 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heat Sensitivity Scale Total Score (time frame: Baseline (at the time of questionnaire administration)). 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 22 Jul 2026.