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RecruitingNCT07850674Updated Sep 30, 2026

Spinal Mobility, Rigidity, and Kinesiophobia in PD and TMD

An observational study in PARKINSON DISEASE (Disorder), Rigidity and Temporomandibular Disorders (TMDs), sponsored by Mustafa Kemal University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Mustafa Kemal University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • PARKINSON DISEASE (Disorder)
  • Rigidity
  • Temporomandibular Disorders (TMDs)
  • Mobility

Keywords

  • parkınson
  • rigidity
  • mobility
  • temporomandibular disorders
03

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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

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
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Parkinson's Disease with TMD
  • Parkinson's Disease without TMD
05

What researchers measure

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)

    Time frame: Baseline (measured once during a single evaluation session)

Secondary outcomes

  1. Axial Rigidity

    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)

    Time frame: Baseline (single evaluation session)

  2. Kinesiophobia Level

    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)

    Time frame: Baseline (single evaluation session)

  3. Postural Alignment and Forward Head Posture

    Assessed via MDS-UPDRS item 3.13 (Posture, score 0-4) and Craniovertebral Angle measurement using a goniometer (degrees)

    Time frame: Baseline (single evaluation session)

  4. Temporomandibular Joint Range of Motion

    Maximum mouth opening, protrusion, retrusion, and bilateral lateral excursion measured in millimeters using a millimeter ruler.

    Time frame: Baseline (single evaluation session)

06

Study locations

1 of 1 sites recruiting
  • Hatay Mustafa Kemal Universty
    Hatay, Turkey (Türkiye)
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07850674
Lead sponsor
Mustafa Kemal University
Responsible party
İsmail KARA (İsmail Kara, Mustafa Kemal University) — Principal investigator
First posted
Sep 30, 2026
Start date
Sep 23, 2026
Primary completion
Dec 23, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 30, 2026

Study contacts

derya yavuz demiray
Contact
deryayavuz149@gmail.com
+90 5305146831

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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