- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07850674
Spinal Mobility, Rigidity, and Kinesiophobia in PD and TMD
A Comparative Study of Spinal Mobility, Axial Rigidity, and Kinesiophobia Between Parkinson's Disease Patients With and Without Temporomandibular Disorders
Axial rigidity and loss of spinal mobility commonly observed in Parkinson's disease (PD) lead to postural deformities and substantial reductions in trunk flexibility. This condition can impair the biomechanics of the craniocervical and lumbopelvic kinetic chain, potentially exerting a negative impact on temporomandibular joint (TMJ) functions. In this context, the planned study aims to determine whether differences exist in spinal mobility, axial rigidity, and kinesiophobia levels between individuals with PD with and without Temporomandibular Disorders (TMD), and to investigate whether a biomechanical relationship exists between TMD and spinal mobility, axial rigidity, and kinesiophobia levels in this population.
The study will be conducted face-to-face at the Neurology Outpatient Clinic of Hatay Mustafa Kemal University Research and Training Hospital. Individuals aged 40-75 years, diagnosed with PD, staged between 1.5 and 4 according to the Hoehn and Yahr Scale, with a Mini-Mental State Examination score of 24 or higher (MMSE ≥ 24), and in the "ON" state during the evaluation will be included. Individuals with a history of cervical, lumbar, maxillofacial, or TMJ surgery that could directly affect spinal mobility and posture; acute orthopedic or rheumatologic disorders that would preclude testing (e.g., advanced Ankylosing Spondylitis); comorbid neurological conditions (e.g., stroke, multiple sclerosis); complete edentulism or severe disruption of oral anatomy; active toothache; pregnancy or suspected pregnancy; and severe psychiatric disorders will be excluded. Written informed consent will be obtained from all participants, and the study will be conducted on a voluntary basis. All data will remain confidential and be utilized solely for scientific purposes.
In this cross-sectional study, evaluations will be carried out in a single session for each participant. Following the recording of demographic and clinical characteristics, the presence of TMD will be assessed using the Fonseca Anamnestic Index, jaw range of motion with a millimeter ruler, and spinal mobility using the modified-modified Schober test, tragus-to-wall distance, intermalleolar distance, and occiput-to-wall distance measurements. Axial rigidity will be evaluated using item 3.3 (Rigidity) of the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), posture will be assessed using MDS-UPDRS item 3.13 (Posture) alongside craniovertebral angle measurement, and kinesiophobia will be assessed via the Tampa Scale for Kinesiophobia.
The resulting findings are expected to contribute to understanding the impact of spinal mobility, axial rigidity, and kinesiophobia on the temporomandibular system in PD, offering valuable clinical guidance for assessment, physiotherapy, and multidisciplinary neurological rehabilitation pathways.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: derya yavuz demiray
- Phone Number: +90 5305146831
- Email: deryayavuz149@gmail.com
Study Locations
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Hatay, Turkey (Türkiye)
- Recruiting
- Hatay Mustafa Kemal Universty
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Contact:
- derya yavuz demiray
- Phone Number: +905305146831
- Email: deryayavuz149@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study population consists of individuals aged 40-75 years diagnosed with Parkinson's disease (Modified Hoehn & Yahr stages 1.5-4) who are admitted to the Neurology Outpatient Clinic of Hatay Mustafa Kemal University Research and Training Hospital.
Description
Inclusion Criteria:
- Diagnosed with Parkinson's disease
- Modified Hoehn & Yahr stages 1.5 to 4
- Mini-Mental State Examination (MMSE) score ≥ 24
- Evaluated during the medication "ON" state
Exclusion Criteria:
- History of cervical, lumbar, maxillofacial, or temporomandibular joint surgery -Acute orthopedic or severe rheumatologic disease (e.g., advanced ankylosing spondylitis)
- Additional comorbid neurological disorders (e.g., stroke, multiple sclerosis)
- Complete edentulism or severe disruption of oral anatomy
- Ongoing acute dental pain
- Pregnancy or suspected pregnancy
- Severe psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
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Parkinson's Disease with TMD
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Parkinson's Disease without TMD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Spinal Mobility
Time Frame: Baseline (measured once during a single evaluation session)
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Assessed through Modified-Modified Schober Test (cm), Tragus-to-Wall Distance (cm), Occiput-to-Wall Distance (cm), and Intermalleolar Distance (cm) |
Baseline (measured once during a single evaluation session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Axial Rigidity
Time Frame: Baseline (single evaluation session)
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Assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, item 3.3 (Rigidity). Scores range from 0 (normal) to 4 (severe) |
Baseline (single evaluation session)
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|
Kinesiophobia Level
Time Frame: Baseline (single evaluation session)
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Evaluated using the Tampa Scale for Kinesiophobia (TSK; 17 items, 4-point Likert scale, total score range: 17-68, where higher scores indicate greater fear of movement) |
Baseline (single evaluation session)
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|
Postural Alignment and Forward Head Posture
Time Frame: Baseline (single evaluation session)
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Assessed via MDS-UPDRS item 3.13 (Posture, score 0-4) and Craniovertebral Angle measurement using a goniometer (degrees) |
Baseline (single evaluation session)
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Temporomandibular Joint Range of Motion
Time Frame: Baseline (single evaluation session)
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Maximum mouth opening, protrusion, retrusion, and bilateral lateral excursion measured in millimeters using a millimeter ruler. |
Baseline (single evaluation session)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Muscular Diseases
- Muscle Hypertonia
- Neuromuscular Manifestations
- Joint Diseases
- Jaw Diseases
- Neurodegenerative Diseases
- Mandibular Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Craniomandibular Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Parkinson Disease
- Temporomandibular Joint Disorders
- Muscle Rigidity
Other Study ID Numbers
- HMKU-PD-TMD-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared in order to protect participant confidentiality and privacy in accordance with ethical committee regulations. De-identified study data may be made available from the corresponding author upon reasonable academic request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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