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临床试验/NCT07448883
NCT07448883招募中不适用

Validity, Reliability, and Clinical Correlation Study of the Turkish Translation of the Modified JOA (Japanese Orthopedic Association) Cervical Myelopathy Score

Izmir Democracy University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年5月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Modified Japanese Orthopedic Association Score

研究概览

简要总结

Degenerative cervical myelopathy (DCM) is the most common cause of non-traumatic spinal cord dysfunction in adults and may lead to progressive motor, sensory, and autonomic impairment. Accurate and standardized assessment of neurological function is essential for clinical decision-making, prognostic evaluation, and comparison of treatment outcomes. The Modified Japanese Orthopaedic Association (mJOA) score is one of the most widely used clinician-based outcome measures for evaluating neurological status in patients with DCM. Although the mJOA has been translated and validated in several languages, no validated Turkish version currently exists.

This prospective, cross-sectional validation study aims to culturally adapt the mJOA score into Turkish and evaluate its validity, reliability, and clinical correlation in Turkish-speaking patients diagnosed with DCM. Adult patients (≥18 years) with clinically and radiologically confirmed DCM presenting to the outpatient clinics of Physical Medicine and Rehabilitation and Neurosurgery will be included. Previously obtained cervical magnetic resonance imaging will be reviewed retrospectively to determine myelomalacia levels, while clinical scales will be administered prospectively.

Construct validity will be assessed by examining correlations between the Turkish mJOA scores and the Neck Disability Index, as well as the Nurick grading system. Inter-rater reliability will be evaluated using the Intraclass Correlation Coefficient (ICC [2,1]) between two independent evaluators, and test-retest reliability will be assessed in clinically stable patients after 7-14 days. Feasibility will be evaluated by recording the administration time and potential difficulties during application.

This study is expected to provide a valid and reliable Turkish version of the mJOA score, facilitating standardized assessment of DCM in Turkish clinical practice and enabling comparability with international research.

详细描述

Degenerative cervical myelopathy (DCM) represents the leading cause of non-traumatic spinal cord dysfunction in adults and is characterized by progressive neurological impairment involving upper and lower extremity motor function, sensory deficits, and sphincter dysfunction. Standardized and reliable clinical assessment tools are essential for determining disease severity, guiding treatment decisions, and ensuring comparability across clinical studies.

The Modified Japanese Orthopaedic Association (mJOA) score is a clinician-based functional assessment tool widely used to evaluate neurological status in patients with DCM. It assesses four domains: upper extremity motor function (0-5 points), lower extremity motor function (0-7 points), sensory function (0-3 points), and sphincter function (0-3 points), yielding a total score ranging from 0 to 18. Lower scores indicate more severe neurological impairment. Although the mJOA score has undergone cross-cultural adaptation and validation in several languages, a culturally adapted and psychometrically validated Turkish version is currently unavailable.

This study is designed as a prospective, cross-sectional validation study aiming to perform the cultural adaptation and psychometric evaluation of the Turkish version of the mJOA score in patients with DCM. The translation process was conducted using a standardized forward-backward translation methodology in accordance with internationally accepted cross-cultural adaptation guidelines.

Participants will include adult patients (≥18 years) with clinically and radiologically confirmed DCM who present to the outpatient clinics of Physical Medicine and Rehabilitation and Neurosurgery. Previously obtained cervical magnetic resonance imaging (MRI) scans will be reviewed retrospectively to determine the level of cervical myelomalacia. Demographic and clinical variables, including age, sex, body mass index, symptom duration, treatment status, and affected side, will be recorded.

Construct validity will be evaluated by analyzing correlations between Turkish mJOA total and subdomain scores and the Neck Disability Index (NDI), a validated Turkish instrument measuring cervical disability. Given that higher mJOA scores reflect better neurological function and higher NDI scores indicate greater disability, a significant negative correlation is hypothesized. Additionally, correlations between mJOA scores and the Nurick grading system will be assessed using Spearman's rank correlation analysis. Differences in mJOA scores across categorized Nurick severity groups will be analyzed using non-parametric statistical tests.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older
  • Patients diagnosed with degenerative cervical myelopathy using clinical or magnetic resonance imaging
  • Able to provide written informed consent to participate in the study
  • Cognitive competence to understand Turkish forms and scales

排除标准

  • Spinal cord injury due to trauma, tumor, infection, inflammatory diseases, etc., pathologies
  • Previous cervical surgery
  • Severe cognitive impairment or communication problems that would prevent participation in the study
  • Subjects who were informed about the study but refused to participate

研究组 & 干预措施

degenerative cervical miyelopathy

结局指标

主要结局

Modified Japanese Orthopedic Association Score

时间窗: Day 1

The Modified Japanese Orthopedic Association Score is a clinician-based functional assessment scale used to evaluate neurological function in patients with DSM. The scale covers four main areas: upper extremity motor function, lower extremity motor function, sensory function, and bladder (sphincter) function. Upper extremity motor function is scored from 0 to 5 points, lower extremity motor function from 0 to 7 points, sensory function from 0 to 3 points, and sphincter function from 0 to 3 points. The total score ranges from 0 to 18. Lower scores indicate more severe neurological dysfunction and poorer clinical status, while higher scores indicate better neurological function and clinical improvement. The scale is applied based on clinical examination findings and is a practical assessment tool that can be completed in a short time.

Neck Disability Index

时间窗: Day 1

The Neck Disability Index is an adaptation of the Oswestry Disability Index for the cervical region and is a widely used 10-item questionnaire for assessing cervical dysfunction and neck pain. Each item is scored between 0 (no disability) and 5 (complete disability). The total score ranges from 0 to 50; a higher score indicates greater functional limitation. The questionnaire has established validity and reliability in Turkish.

次要结局

  • Nurick Grading System(Day 1)

研究者

发起方
Izmir Democracy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kadir Songur

Dr. Lecturer

Izmir Democracy University

研究点 (1)

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