Proprioceptive Deficits in Degenerative Cervical Myelopathy

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05183971
Collaborator
(none)
500
1
176
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Proprioceptive Functional Analysis System

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Early Detection of Proprioceptive Dysfunction in Degenerative Cervical Myelopathy by Proprioceptive Functional Analysis in Activities of Daily Living
Anticipated Study Start Date :
Jan 31, 2022
Anticipated Primary Completion Date :
Sep 30, 2035
Anticipated Study Completion Date :
Sep 30, 2036

Arms and Interventions

Arm Intervention/Treatment
(1) Degenerative Cervical Myelopathy

Chinese subjects aged 40 or above who have radiological evidences of Degenerative Cervical Myelopathy, both symptomatic and asymptomatic with Nurick Grade less than 3 will be included.

Other: Proprioceptive Functional Analysis System
Proprioceptive testing and Physical Performance Tests

(2) Healthy Controls

Chinese healthy controls aged 40 or above who have no myelopathic sign of Degenerative Cervical Myelopathy with Nurick Grade less than 3 will be included.

Other: Proprioceptive Functional Analysis System
Proprioceptive testing and Physical Performance Tests

Outcome Measures

Primary Outcome Measures

  1. Modified Japanese Orthopaedics Association Scoring System for Cervical Myelopathy (mJOA) [15 years]

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

Secondary Outcome Measures

  1. Proprioceptive Deficits [15 years]

    Proprioceptive deficits hinder the limb coordination, especially the fine finger dexterity, reciprocal walking and stepping. Thus, incoordination over the lower and upper limbs will then be resulted and which alters the speed and integrity of the performance in the Physical Performance Tests validated for DCM. In the physical performance tests, the performance will be recorded for analysis in terms of: time of completion total number of repetitions

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Chinese

  • Aged 40 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 40

  • without any radiological proof of cervical myelopathy

  • Active problems of tuberculosis spine, lumbar spinal diseases and other problem 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 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 in expressing their own symptoms clearly

  • Non-walker

  • Blind or deaf

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Duchess of Kent Children's Hospital at Sandy Bay Hong Kong Hong Kong 000

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Karlen Ka Pui Law, M. Phil, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05183971
Other Study ID Numbers:
  • UW 20-746
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022