NCT07710625

Brief 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 construct validity, in order to provide a valid and reliable tool for assessing temperature sensitivity in Turkish-speaking individuals with Parkinson's disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
May 2026May 2027

Study Start

First participant enrolled

May 25, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 14, 2026

Last Update Submit

July 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (at the time of questionnaire administration)

Secondary Outcomes (1)

  • Parkinson's Disease Questionnaire-39 (PDQ-39) Total and Subscale Scores

    Baseline (at the time of questionnaire completion)

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Turkey, +90, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Nuray Alaca

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

May 25, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

May 25, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations