Cervical MyelopathyNCT03304236
Motion Analysis of the Myelopathy Hand: New Insight Into the Classical Sign
An observational study of Cervical Myelopathy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- Myelopathy Hand
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2017to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at the Duchess of Kent Children's Hospital will be selected.
Who may be able to join
- All degenerative causes of documented cervical myelopathy planned for operation will be recruited into the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cervical Myelopathy
- Being tested
- Myelopathy Hand
- Keywords
- Cervical Myelopathy, sEMG, Motion capture analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myelopathy HandDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Myelopathy Hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis
Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis
Measured: 1 year
Secondary outcomes (3)
Correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis
To correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis
Measured: 1 year
Correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis
To correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis
Measured: 1 year
Devise a new severity score based on different patterns of hand movement using sEMG and motion capture analysis
To devise a new severity score based on different patterns of hand movement nursing sEMG and motion capture analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Jul 2017
- Primary completion31 Mar 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Dr. Kenny Kwan, The University of Hong Kong
- Investigators
- Dr Kenny Kwan, BMBCh(Oxon), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304236
- Sponsor's protocol ID
- UW 17-174
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2017
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ono K, Okada K and Fuji T. Finger escape sign (FES), an objective sign signifying pyramidal tract involvement of the cervical spinal cord. Orthop Trans 1982; 6.2:181.
Ono K, Ebara S, Fuji T, Yonenobu K, Fujiwara K, Yamashita K. Myelopathy hand. New clinical signs of cervical cord damage. J Bone Joint Surg Br. 1987 Mar;69(2):215-9. doi: 10.1302/0301-620X.69B2.3818752.
PubMed 3818752Taylor T, Ko S, Mastrangelo C, Bamberg SJ. Forward kinematics using IMU on-body sensor network for mobile analysis of human kinematics. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:1230-3. doi: 10.1109/EMBC.2013.6609729.
PubMed 24109916
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Analysis of the Myelopathy Hand: New Insight Into the Classical Sign
- ClinicalTrials.gov ID
- NCT03304236
- Acronym / sponsor ID
- UW 17-174
- Conditions
- Cervical Myelopathy
- Keywords
- Cervical Myelopathy, sEMG, Motion capture analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myelopathy hand | – | Device: Myelopathy HandPatients 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at the Duchess of Kent Children's Hospital will be selected.
Key inclusion criteria (1 listed)
- All degenerative causes of documented cervical myelopathy planned for operation will be recruited into the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myelopathy HandPatients 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 |
Primary outcome
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
3 secondary outcomes
Correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis
Time frame: 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
Devise a new severity score based on different patterns of hand movement using sEMG and motion capture analysis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- BackgroundOno K, Okada K and Fuji T. Finger escape sign (FES), an objective sign signifying pyramidal tract involvement of the cervical spinal cord. Orthop Trans 1982; 6.2:181.
- Background: PubMed 3818752Ono K, Ebara S, Fuji T, Yonenobu K, Fujiwara K, Yamashita K. Myelopathy hand. New clinical signs of cervical cord damage. J Bone Joint Surg Br. 1987 Mar;69(2):215-9. doi: 10.1302/0301-620X.69B2.3818752.
- Background: PubMed 24109916Taylor T, Ko S, Mastrangelo C, Bamberg SJ. Forward kinematics using IMU on-body sensor network for mobile analysis of human kinematics. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:1230-3. doi: 10.1109/EMBC.2013.6609729.
- Individual participant dataSharing planned: No
Related trials for Cervical Myelopathy
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Stimulation-based Therapy to Improve Balance in DCM
Degenerative Cervical Myelopathy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Kenny Kwan, BMBCh(Oxon) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Myelopathy, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03304236, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.