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

October 2, 2021 updated by: Dr. Kenny Kwan, The University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Duchess of Kent Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at the Duchess of Kent Children's Hospital will be selected.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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 nursing sEMG and motion capture analysis
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW 17-174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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