Parkinson DiseaseNCT07488364
Determinants of Physical Frailty in Parkinson's Disease: A Multi-Factorial Analysis
An observational study of Parkinson Disease, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Observational Questionnaire and Functional Assessment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2026to 30 Mar 2027
- How long will I take part?
- 1 Day
- 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
- 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
Who cannot join
- 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
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: Investigation of the Relationship Between Motor Imagery, Body Awareness, Kinesiophobia, Physical Activity, Symptom Severity, and Physical Frailty in Patients With Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Being tested
- Observational Questionnaire and Functional Assessment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Questionnaire and Functional AssessmentOther
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 analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) Total and Subscale Scores
Motor imagery ability will be assessed using the Vividness of Movement Imagery Questionnaire-2 (VMIQ-2), a validated self-report instrument with established Turkish validity and reliability. The questionnaire consists of 12 items assessing the vividness of imagined movements across three domains: external visual imagery, internal visual imagery, and kinesthetic imagery. Each item is rated on a 5-point Likert scale (1-5), and separate scores are calculated for each subscale as well as a total score. Total scores range from 17 to 68, with higher scores indicating lower vividness of motor imagery ability. Assessments will be administered jointly by the responsible physician and a physiotherapist.
Measured: Baseline (at the time of questionnaire administration)
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) Total and Subscale Scores
Interoceptive body awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), a validated self-report instrument with established Turkish validity and reliability. The Turkish version consists of 34 items across seven subscales: Noticing, Not-Distracting, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Each item is rated on a 6-point Likert scale ranging from 0 (never) to 5 (always). Subscale scores are calculated separately, with higher scores indicating greater interoceptive body awareness in the respective domain.
Measured: Baseline (at the time of questionnaire administration)
Fried Frailty Phenotype (FFP) Classification and Total Criteria Score
Physical frailty will be assessed using the Fried Frailty Phenotype (FFP), a validated measure based on five criteria: unintentional weight loss, exhaustion, low physical activity, weak handgrip strength, and slow walking speed. Participants will be classified as robust (0 criteria), prefrail (1-2 criteria), or frail (≥3 criteria). Each criterion will be scored as present or absent, and a total score ranging from 0 to 5 will be calculated. In addition to the original criteria, population-specific cut-off values for handgrip strength (≤13.6 kg for women and ≤27.7 kg for men) will be applied. Higher scores indicate greater frailty.
Measured: Baseline (at the time of physical and questionnaire-based assessment)
Secondary outcomes (3)
Tampa Scale for Kinesiophobia (TSK) Total Score
Kinesiophobia (fear of movement) will be assessed using the Tampa Scale for Kinesiophobia (TSK), a validated 17-item self-report questionnaire evaluating fear of movement and re-injury. Each item is rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). The total score ranges from 17 to 68, with higher scores indicating greater fear of movement. The Turkish version of the scale has demonstrated validity and reliability in clinical populations.
Measured: Baseline (at the time of questionnaire administration)
Physical Activity Scale for the Elderly (PASE) Total Score
Physical activity level will be assessed using the Physical Activity Scale for the Elderly (PASE), a validated self-report questionnaire designed to evaluate physical activity in older adults. The scale consists of 12 items covering leisure time activities, household activities, and work-related physical activities performed over the previous 7 days. The total PASE score is calculated by multiplying activity frequency and duration by empirically derived item weights and summing across all activities. Scores range from 0 to over 400, with higher scores indicating higher levels of physical activity.
Measured: Baseline (reflecting physical activity over the previous 7 days)
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Symptom severity will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a validated instrument evaluating motor and non-motor aspects of Parkinson's disease. The scale consists of four parts covering non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications. Each item is rated from 0 (normal) to 4 (severe), and total and subscale scores are calculated. Higher scores indicate greater disease severity.
Measured: Baseline (at the time of clinical assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start30 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 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)
- Target duration
- 1 Day
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
- NCT07488364
- Sponsor's protocol ID
- 2026-03-131
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 15 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07488364
- Acronym / sponsor ID
- 2026-03-131
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 23 Mar 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
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 (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Observational Questionnaire and Functional AssessmentThis 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 analysis. | Other | – |
Primary outcome
Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) Total and Subscale Scores
Time frame: Baseline (at the time of questionnaire administration)
Motor imagery ability will be assessed using the Vividness of Movement Imagery Questionnaire-2 (VMIQ-2), a validated self-report instrument with established Turkish validity and reliability. The questionnaire consists of 12 items assessing the vividness of imagined movements across three domains: external visual imagery, internal visual imagery, and kinesthetic imagery. Each item is rated on a 5-point Likert scale (1-5), and separate scores are calculated for each subscale as well as a total score. Total scores range from 17 to 68, with higher scores indicating lower vividness of motor imagery ability. Assessments will be administered jointly by the responsible physician and a physiotherapist.
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) Total and Subscale Scores
Time frame: Baseline (at the time of questionnaire administration)
Interoceptive body awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), a validated self-report instrument with established Turkish validity and reliability. The Turkish version consists of 34 items across seven subscales: Noticing, Not-Distracting, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Each item is rated on a 6-point Likert scale ranging from 0 (never) to 5 (always). Subscale scores are calculated separately, with higher scores indicating greater interoceptive body awareness in the respective domain.
Fried Frailty Phenotype (FFP) Classification and Total Criteria Score
Time frame: Baseline (at the time of physical and questionnaire-based assessment)
Physical frailty will be assessed using the Fried Frailty Phenotype (FFP), a validated measure based on five criteria: unintentional weight loss, exhaustion, low physical activity, weak handgrip strength, and slow walking speed. Participants will be classified as robust (0 criteria), prefrail (1-2 criteria), or frail (≥3 criteria). Each criterion will be scored as present or absent, and a total score ranging from 0 to 5 will be calculated. In addition to the original criteria, population-specific cut-off values for handgrip strength (≤13.6 kg for women and ≤27.7 kg for men) will be applied. Higher scores indicate greater frailty.
3 secondary outcomes
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)
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 15 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, 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 6 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 15 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?
Contact Nuray ALACA (05324251290, nuray.alaca@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) Total and Subscale Scores (time frame: Baseline (at the time of questionnaire administration)). The study lists 3 primary outcomes in all. 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 15 Jul 2026.