Proprioceptive Deficits in Degenerative Cervical Myelopathy

NCT05183971 | Recruiting

• 1 other identifier: UW 20-746
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Myelopathy

Keywords

Degenerative Cervical Myelopathy; Proprioceptive Deficits

Outcome Measures

Primary Outcomes (1)

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

  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

  15 years

Secondary Outcomes (2)

• Proprioceptive Deficits - Speed Test

  15 years

• Proprioceptive Deficits - Time Limited Test

  15 years

Study Arms (2)

(1) Degenerative Cervical Myelopathy

Chinese subjects aged 50 or above who have radiological evidence of Degenerative Cervical Myelopathy, symptomatic with Nurick Grade less than 3 will be included.

Other: Proprioceptive Functional Analysis System

(2) Healthy Controls

Chinese healthy controls aged 50 or above who have no myelopathic signs of Degenerative Cervical Myelopathy with Nurick Grade less than 3 will be included.

Other: Proprioceptive Functional Analysis System

Interventions

Proprioceptive Functional Analysis System OTHER

Proprioceptive testing and Physical Performance Tests

(1) Degenerative Cervical Myelopathy; (2) Healthy Controls

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Radiologically confirmed with Degenerative Cervical Myelopathy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The Duchess of Kent Children's Hospital at Sandy Bay

Hong Kong, 000, Hong Kong

RECRUITING

Study Officials

• Karlen Ka Pui Law, M. Phil

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karlen Ka Pui Law, M. Phil

CONTACT

852-29740531; karlenhk@connect.com.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 11, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 30, 2035
• Study Completion (Estimated): September 30, 2036
• Last Updated: July 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)