NCT07850674

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 23, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

parkınsonrigiditymobilitytemporomandibular disorders

Outcome Measures

Primary Outcomes (1)

  • Spinal Mobility

    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 Outcomes (4)

  • Axial Rigidity

    Baseline (single evaluation session)

  • Kinesiophobia Level

    Baseline (single evaluation session)

  • Postural Alignment and Forward Head Posture

    Baseline (single evaluation session)

  • Temporomandibular Joint Range of Motion

    Baseline (single evaluation session)

Study Arms (2)

Parkinson's Disease with TMD

Parkinson's Disease without TMD

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal Universty

Hatay, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMuscle RigidityTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesJoint DiseasesStomatognathic Diseases

Central Study Contacts

derya yavuz demiray

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
İsmail Kara

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

September 23, 2026

Primary Completion (Estimated)

December 23, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations