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- Ensaio 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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: derya yavuz demiray
- Número de telefone: +90 5305146831
- E-mail: deryayavuz149@gmail.com
Locais de estudo
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Hatay, Turquia (Türkiye)
- Recrutamento
- Hatay Mustafa Kemal Universty
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Contato:
- derya yavuz demiray
- Número de telefone: +905305146831
- E-mail: deryayavuz149@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: CROSS_SECTIONAL
Coortes e Intervenções
Grupo / Coorte |
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Parkinson's Disease with TMD
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Parkinson's Disease without TMD
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Spinal Mobility
Prazo: 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)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Axial Rigidity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sinucleinopatias
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças estomatognáticas
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Musculares
- Hipertonia muscular
- Manifestações Neuromusculares
- Doenças articulares
- Doenças dos maxilares
- Doenças Neurodegenerativas
- Doenças Mandibulares
- Distúrbios do Movimento
- Distúrbios parkinsonianos
- Doenças dos Gânglios da Base
- Desordens Craniomandibulares
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Doença de Parkinson
- Distúrbios da Articulação Temporomandibular
- Rigidez Muscular
Outros números de identificação do estudo
- HMKU-PD-TMD-45
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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