- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: derya yavuz demiray
- Número de teléfono: +90 5305146831
- Correo electrónico: deryayavuz149@gmail.com
Ubicaciones de estudio
-
-
-
Hatay, Turquía (Türkiye)
- Reclutamiento
- Hatay Mustafa Kemal Universty
-
Contacto:
- derya yavuz demiray
- Número de teléfono: +905305146831
- Correo electrónico: deryayavuz149@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Parkinson's Disease with TMD
|
|
Parkinson's Disease without TMD
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Spinal Mobility
Periodo de tiempo: Baseline (measured once during a single evaluation session)
|
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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Axial Rigidity
Periodo de tiempo: Baseline (single evaluation session)
|
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)
|
|
Kinesiophobia Level
Periodo de tiempo: Baseline (single evaluation session)
|
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)
|
|
Postural Alignment and Forward Head Posture
Periodo de tiempo: Baseline (single evaluation session)
|
Assessed via MDS-UPDRS item 3.13 (Posture, score 0-4) and Craniovertebral Angle measurement using a goniometer (degrees) |
Baseline (single evaluation session)
|
|
Temporomandibular Joint Range of Motion
Periodo de tiempo: Baseline (single evaluation session)
|
Maximum mouth opening, protrusion, retrusion, and bilateral lateral excursion measured in millimeters using a millimeter ruler. |
Baseline (single evaluation session)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades Estomatognáticas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Musculares
- Hipertonía muscular
- Manifestaciones Neuromusculares
- Enfermedades Articulares
- Enfermedades de la mandíbula
- Enfermedades neurodegenerativas
- Enfermedades mandibulares
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos Craneomandibulares
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedad de Parkinson
- Trastornos de la articulación temporomandibular
- Rigidez muscular
Otros números de identificación del estudio
- HMKU-PD-TMD-45
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .