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Trial record 4 of 669 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Marrow Diseases"

Motion Analysis of the Myelopathy Hand: New Insight Into the Classical Sign

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ClinicalTrials.gov Identifier: NCT03304236
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Dr. Kenny Kwan, The University of Hong Kong

Brief Summary:
This study aims to quantify the clumsiness and decreased dexterity seen in the grip and release test using a simple glove with sensors that can quantify the abnormal motion of this classical sign. This new tool will give a mechanistic insight into the myelopathy. The findings of this study will also form the basis of a prospective longitudinal study with clinical and radiological evaluation to compare the prognosticating value of this new information in clinical practice.

Condition or disease Intervention/treatment
Cervical Myelopathy Device: Myelopathy Hand

Detailed Description:

Cervical myelopathy is a common condition due to degeneration of the cervical spine causing stenosis and cord compression, with a higher prevalence in Asian population. It leads to decreased hand dexterity and function, sensory loss, gait and sphincter disturbance. Natural history shows a stepwise deterioration in most cases, whilst a slow progressive deterioration or sudden deterioration is observed in small number of subjects.

The myelopathy hand was first described by Ono et al. on the analysis of finger motion impairment caused by cervical myelopathy. They described a 10 second grip and release test, which documents the number of times a subject can make a fist and release it as rapidly as possible within 10 seconds. The clumsiness associated with intrinsic finger weakness decreases the number of cycles a patient can perform during the test. They quantified patients' neurologic deficit and found that <20 grip -release cycles in 10 seconds represented symptomatic myelopathy. The presence of this sign is not only pathognomonic of cervical myelopathy but also correlates with disease severity. This is a sensitive and specific sign of pyramidal tract involvement and has since become a classical sign and objective test of the condition. The presence of myelopathic hand signs aids the diagnosis of symptomatic cervical myelopathy and its grading acts a guide to the severity of the condition to the treating surgeon.

However, this quantitative analysis only provides a crude representation of the clumsiness that patients experience from their deterioration of hand function. In the original description, Ono et al. noted the quality of this movement was affected particularly in advanced cases, where there was difficult, slow and incomplete finger extension, exaggerated wrist flexion with attempted finger extension and exaggerated wrist extension with finger flexion. This was considered to be caused by a failure of synergy between the wrist and the fingers. Finger motion is complex, varies greatly and clinical evaluation is often difficult. Apart from the counting the number of cycles a patient can perform, the classical grip and release test contains other critical clinical information that has been widely described by surgeons but in very vague terms that are neither reproducible nor meaningful in clinical practice. Although this uncoordinated finger motion and inability to move their fingers smoothly in grip and release cycles are well-known phenomena in myelopathy patients, they have been only vaguely recognized. Presently these kinematic characteristics have not been quantified or studied, and it is not known which types of myelopathy present with them, how it correlates with disease severity and its prognosticating value.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Motion Analysis of the Myelopathy Hand: New Insight Into the Classical Sign
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Myelopathy hand
Patients will undergo radiological and clinical examination at the Duchess of Kent Children Hospital. Patients will be required to put on a pair of hand gloves with 18 IMUs located on specific bony landmarks (distal phalanges of fingers, proximal phalanges of index fingers and thumbs, dorsum of the hands and bilateral wrists).
Device: Myelopathy Hand
Patients will undergo radiological and clinical examination at the Duchess of Kent Children Hospital. Patients will be required to put on a pair of hand gloves with 18 IMUs located on specific bony landmarks (distal phalanges of fingers, proximal phalanges of index fingers and thumbs, dorsum of the hands and bilateral wrists)




Primary Outcome Measures :
  1. Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis [ Time Frame: 1 year ]
    Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis


Secondary Outcome Measures :
  1. Correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis [ Time Frame: 1 year ]
    To correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis

  2. Correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis [ Time Frame: 1 year ]
    To correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis

  3. Devise a new severity score based on different patterns of hand movement using sEMG and motion capture analysis [ Time Frame: 1 year ]
    To devise a new severity score based on different patterns of hand movement nusing sEMG and motion capture analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the Duchess of Kent Children's Hospital will be selected.
Criteria

Inclusion Criteria:

  • All degenerative causes of documented cervical myelopathy planned for operation will be recruited into the study.

Exclusion Criteria:

  • Patients found to have spinal tumour, infection, or other non-degenerative causes as well as patient who are unable to follow command and/or unwilling to attend follow up will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304236


Contacts
Contact: Dr Kenny Kwan, BMBCh (Oxon) +85222554654 kyhkwan@hku.hk
Contact: Hui Yu Koh, BSc +85252393556 huiyu.koh@gmail.com

Locations
Hong Kong
Duchess of Kent Children's Hospital Recruiting
Hong Kong, Hong Kong
Contact: Dr Kenny Kwan, BMBCh (Oxon)    +852 22554654    kyhkwan@hku.hk   
Contact: Hui Yu Koh, BSc    +85252393556    huiyu.koh@gmail.com   
Principal Investigator: Dr Kenny Kwan, BMBCh (Oxon)         
Sub-Investigator: Dr Joanne Yip, PhD         
Sponsors and Collaborators
The University of Hong Kong
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Dr Kenny Kwan, BMBCh(Oxon) The University of Hong Kong

Publications:
Responsible Party: Dr. Kenny Kwan, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03304236     History of Changes
Other Study ID Numbers: UW 17-174
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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 Dr. Kenny Kwan, The University of Hong Kong:
Cervical Myelopahty
sEMG
Motion capture analysis

Additional relevant MeSH terms:
Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases