跳至主要内容
临床试验/NCT05183971
NCT05183971招募中不适用

Early Detection of Proprioceptive Dysfunction in Degenerative Cervical Myelopathy by Proprioceptive Functional Analysis in Activities of Daily Living

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Modified Japanese Orthopaedics Association Scoring System for Cervical Myelopathy (mJOA)

研究概览

简要总结

Proprioceptive deficits in degenerative cervical myelopathy (DCM) is a progressive neurological deficits in somatosensory and motor function which affects the body balance and motor control. DCM usually presents with body incoordination, hand clumsiness and gait disturbance associated with proprioceptive dysfunction that hinders the physical performance and functions. In this study, a non-invasive assessment protocol on proprioception will be developed for detecting subtle proprioceptive deficits at the early stage of disease through simple Physical Performance Tests for population older than 45. By adopting the physical performance tests as the diagnostic predictors of DCM, we aim to avoid the development of devastating consequences and disabilities.

详细描述

DCM is a chronic insidious disease, one of the most disabling orthopaedic conditions, which involves compression of the spinal cord by the surrounding structures in cervical spinal region. It characterizes with progressive neurological deficits in body coordination, hand clumsiness and gait disturbance as the preliminary symptom which may cause by proprioceptive dysfunction .

Physical performance and function hinder patients' hand clumsiness, gait disturbance and body imbalance. The incoordination between body, upper limbs and lower limbs will be resulted from proprioceptive deficits caused by spinal cord compression. By adopting the Proprioceptive Functional Analysis System (PFAS), proprioceptive deficits over the core body joints and peripheral joints could be tested during Activity of Daily Living (ADL) with reference to normal subjects' performance. All subjects will be tested by the PFAS and Physical Performance Tests.

The idea of regional proprioceptive deficit will be incorporated in the assessment protocol for DCM to facilitates a breakthrough from the traditional DCM functional evaluation.

In developing a non-invasive assessment protocol to assess proprioceptive deficit, we aim to detect subtle proprioceptive deficit from the tests, especially at the very early stage of disease. We target to demonstrate the validity of Physical Performance Tests are evenly high as that of the advanced technology, PFAS.

Consequently, by adopting the valid Physical Performance Tests in health screening scheme for population older than 45 within the community can serve as an early diagnostic parameter of DCM and avoid delayed treatment leading to devastating consequences and disabilities.

研究设计

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

入排标准

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

入选标准

  • Aged 50 or above
  • With radiological evidence of degenerative cervical myelopathy, both symptomatic and asymptomatic
  • Nurick grade less than 3

排除标准

  • Non-Chinese ethnicity
  • Aged under 50
  • without any radiological proof of cervical myelopathy
  • Active problems of tuberculosis spine, lumbar spinal diseases, and other problems causing pain or deformities over the limbs that may affect their balance and movement
  • Presents with extra-pyramidal or other disorders involving the cerebellum or frontal lobe of the cerebrum leading to poor balance and gait disturbance
  • Previous spinal operation with residual disturbance in balance or gait
  • Non-communicable patients with insufficient cognitive ability to express their symptoms clearly
  • Non-walker
  • Blind or deaf

结局指标

主要结局

Modified Japanese Orthopaedics Association Scoring System for Cervical Myelopathy (mJOA)

时间窗: 15 years

mJOA is a self-reported functional questionnaire on disease severity through assessing 4 domains: 1. Upper Limb Function 2. Lower Limb Function 3. Sensory Function 4. Bladder Function mJOA has a total score of 17 and it categories DCM patient into different severity as below: 1. Mild \>= 15 2. Moderate = 12-14 3. Severe \< 12

次要结局

  • Proprioceptive Deficits - Time Limited Test(15 years)
  • Proprioceptive Deficits - Speed Test(15 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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