Proprioceptive Deficits in Degenerative Cervical Myelopathy

Cervical Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183971
• Other study ID #: UW 20-746
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 30, 2036

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: Karlen Ka Pui Law, M. Phil
• Phone: 852-29740531
• Email: karlenhk[@]connect.com.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2036
• Est. primary completion date: September 30, 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Myelopathy
• Spinal Cord Diseases

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Duchess of Kent Children's Hospital at Sandy Bay	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Japanese Orthopaedics Association Scoring System for Cervical Myelopathy (mJOA)	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	15 years
Secondary	Proprioceptive Deficits - Speed Test	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, it has divided into 2 separate sections, the "Speed Test" will be recorded for in terms of the "Time required to complete" the standardized test process in seconds	15 years
Secondary	Proprioceptive Deficits - Time Limited Test	Time Limited Test of physical performance test will be assessed and data will be recorded in terms of "Total number of repetitions completed" within strictly fixed time frame	15 years