Clinical trial NCT05183971: Proprioceptive Deficits in Degenerative Cervical Myelopathy
Official title: Early Detection of Proprioceptive Dysfunction in Degenerative Cervical Myelopathy by Proprioceptive Functional Analysis in Activities of Daily Living
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Myelopathy
Keywords: Degenerative Cervical Myelopathy
Proprioceptive Deficits
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiologically confirmed with Degenerative Cervical Myelopathy

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Modified Japanese Orthopaedics Association Scoring System for Cervical Myelopathy (mJOA)
timeFrame: 15 years
Secondary outcomes:
measure: Proprioceptive Deficits - Speed Test
timeFrame: 15 years
measure: Proprioceptive Deficits - Time Limited Test
timeFrame: 15 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Duchess of Kent Children's Hospital at Sandy Bay
Study officials:
affiliation: The University of Hong Kong
name: Karlen Ka Pui Law, M. Phil
role: PRINCIPAL_INVESTIGATOR
References: