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Recruiting NCT07488364

Determinants of Physical Frailty in Parkinson's Disease: A Multi-Factorial Analysis

— Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational Questionnaire and Functional Assessment.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigation of the Relationship Between Motor Imagery, Body Awareness, Kinesiophobia, Physical Activity, Symptom Severity, and Physical Frailty in Patients With Parkinson's Disease

Overview

The aim of this study is to examine the associations between motor imagery capacity, body awareness (interoceptive awareness), kinesiophobia, physical activity level, and symptom severity in individuals with Parkinson's disease. In addition, the study aims to evaluate the relationships between these variables and physical frailty. This cross-sectional observational study will provide insight into the biopsychosocial factors associated with frailty in Parkinson's disease.

Interventions

  • Other Observational Questionnaire and Functional Assessment
    This is a non-interventional, cross-sectional observational study. No therapeutic or experimental intervention will be administered. Participants will undergo a comprehensive assessment including validated self-report questionnaires and standardized performance-based tests to evaluate motor imagery capacity, interoceptive body awareness, kinesiophobia, physical activity level, symptom severity, and physical frailty. All data will be collected during a single assessment session for observational

Primary outcome measures

  • Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) Total and Subscale Scores [Time frame: Baseline (at the time of questionnaire administration)]
  • Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) Total and Subscale Scores [Time frame: Baseline (at the time of questionnaire administration)]
  • Fried Frailty Phenotype (FFP) Classification and Total Criteria Score [Time frame: Baseline (at the time of physical and questionnaire-based assessment)]
Secondary outcome measures (3)
  • Tampa Scale for Kinesiophobia (TSK) Total Score [Time frame: Baseline (at the time of questionnaire administration)]
  • Physical Activity Scale for the Elderly (PASE) Total Score [Time frame: Baseline (reflecting physical activity over the previous 7 days)]
  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score [Time frame: Baseline (at the time of clinical assessment)]

Eligibility criteria

Inclusion criteria

  • Clinically diagnosed Parkinson's disease
  • Hoehn and Yahr stage 1-3
  • Age 40 to 85 years
  • Mini-Mental State Examination (MMSE) score ≥24
  • Attending the Movement Disorders Outpatient Clinic, Department of Neurology
  • Able to understand the study procedures and provide written informed consent

Exclusion criteria

  • Major depressive disorder or psychotic disorder
  • Advanced dementia
  • Severe cardiovascular or respiratory disease
  • Uncontrolled chronic systemic disease (e.g., diabetes mellitus or hypertension)
  • Additional neurological or orthopedic conditions that may affect assessment performance
  • Severe visual or hearing impairment that could interfere with study assessments
  • Inability to cooperate with the physiotherapist during study assessments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Acibadem University — Istanbul

Identifiers

NCT: NCT07488364 · 2026-03-131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗