PARKINSON DISEASE (Disorder)NCT07850674
Spinal Mobility, Rigidity, and Kinesiophobia in PD and TMD
An observational study of PARKINSON DISEASE (Disorder) and Rigidity, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Rigidity, Temporomandibular Disorders (TMDs)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2026to 30 Dec 2026
- Phase
- Observational
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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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
Hatay Mustafa Kemal Universty
Hatay
derya yavuz demiray, +905305146831, deryayavuz149@gmail.com
About this study
Official title: 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.
Read more
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.
- Keywords
- parkınson, rigidity, mobility, temporomandibular disorders
- Medical subject headings
- Parkinson Disease, Muscle Rigidity, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease with TMD | Not described | |
| Parkinson's Disease without TMD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Mobility
Assessed through Modified-Modified Schober Test (cm), Tragus-to-Wall Distance (cm), Occiput-to-Wall Distance (cm), and Intermalleolar Distance (cm)
Measured: Baseline (measured once during a single evaluation session)
Secondary outcomes (4)
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)
Measured: Baseline (single evaluation session)
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)
Measured: Baseline (single evaluation session)
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)
Measured: Baseline (single evaluation session)
Temporomandibular Joint Range of Motion
Maximum mouth opening, protrusion, retrusion, and bilateral lateral excursion measured in millimeters using a millimeter ruler.
Measured: Baseline (single evaluation session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start23 Sep 2026
- Primary completion23 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail KARA, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850674
- Sponsor's protocol ID
- HMKU-PD-TMD-45
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.