<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03304236</url>
  </required_header>
  <id_info>
    <org_study_id>UW 17-174</org_study_id>
    <nct_id>NCT03304236</nct_id>
  </id_info>
  <brief_title>Motion Analysis of the Myelopathy Hand: New Insight Into the Classical Sign</brief_title>
  <official_title>Motion Analysis of the Myelopathy Hand: New Insight Into the Classical Sign</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to quantify the clumsiness and decreased dexterity seen in the grip and&#xD;
      release test using a simple glove with sensors that can quantify the abnormal motion of this&#xD;
      classical sign. This new tool will give a mechanistic insight into the myelopathy. The&#xD;
      findings of this study will also form the basis of a prospective longitudinal study with&#xD;
      clinical and radiological evaluation to compare the prognosticating value of this new&#xD;
      information in clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical myelopathy is a common condition due to degeneration of the cervical spine causing&#xD;
      stenosis and cord compression, with a higher prevalence in Asian population. It leads to&#xD;
      decreased hand dexterity and function, sensory loss, gait and sphincter disturbance. Natural&#xD;
      history shows a stepwise deterioration in most cases, whilst a slow progressive deterioration&#xD;
      or sudden deterioration is observed in small number of subjects.&#xD;
&#xD;
      The myelopathy hand was first described by Ono et al. on the analysis of finger motion&#xD;
      impairment caused by cervical myelopathy. They described a 10 second grip and release test,&#xD;
      which documents the number of times a subject can make a fist and release it as rapidly as&#xD;
      possible within 10 seconds. The clumsiness associated with intrinsic finger weakness&#xD;
      decreases the number of cycles a patient can perform during the test. They quantified&#xD;
      patients' neurologic deficit and found that &amp;lt;20 grip -release cycles in 10 seconds&#xD;
      represented symptomatic myelopathy. The presence of this sign is not only pathognomonic of&#xD;
      cervical myelopathy but also correlates with disease severity. This is a sensitive and&#xD;
      specific sign of pyramidal tract involvement and has since become a classical sign and&#xD;
      objective test of the condition. The presence of myelopathic hand signs aids the diagnosis of&#xD;
      symptomatic cervical myelopathy and its grading acts a guide to the severity of the condition&#xD;
      to the treating surgeon.&#xD;
&#xD;
      However, this quantitative analysis only provides a crude representation of the clumsiness&#xD;
      that patients experience from their deterioration of hand function. In the original&#xD;
      description, Ono et al. noted the quality of this movement was affected particularly in&#xD;
      advanced cases, where there was difficult, slow and incomplete finger extension, exaggerated&#xD;
      wrist flexion with attempted finger extension and exaggerated wrist extension with finger&#xD;
      flexion. This was considered to be caused by a failure of synergy between the wrist and the&#xD;
      fingers. Finger motion is complex, varies greatly and clinical evaluation is often difficult.&#xD;
      Apart from the counting the number of cycles a patient can perform, the classical grip and&#xD;
      release test contains other critical clinical information that has been widely described by&#xD;
      surgeons but in very vague terms that are neither reproducible nor meaningful in clinical&#xD;
      practice. Although this uncoordinated finger motion and inability to move their fingers&#xD;
      smoothly in grip and release cycles are well-known phenomena in myelopathy patients, they&#xD;
      have been only vaguely recognized. Presently these kinematic characteristics have not been&#xD;
      quantified or studied, and it is not known which types of myelopathy present with them, how&#xD;
      it correlates with disease severity and its prognosticating value.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis</measure>
    <time_frame>1 year</time_frame>
    <description>Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis</measure>
    <time_frame>1 year</time_frame>
    <description>To correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis</measure>
    <time_frame>1 year</time_frame>
    <description>To correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Devise a new severity score based on different patterns of hand movement using sEMG and motion capture analysis</measure>
    <time_frame>1 year</time_frame>
    <description>To devise a new severity score based on different patterns of hand movement nursing sEMG and motion capture analysis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Cervical Myelopathy</condition>
  <arm_group>
    <arm_group_label>Myelopathy hand</arm_group_label>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Myelopathy Hand</intervention_name>
    <description>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)</description>
    <arm_group_label>Myelopathy hand</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at the Duchess of Kent Children's Hospital will be selected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All degenerative causes of documented cervical myelopathy planned for operation will&#xD;
             be recruited into the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients found to have spinal tumour, infection, or other non-degenerative causes as&#xD;
             well as patient who are unable to follow command and/or unwilling to attend follow up&#xD;
             will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Kenny Kwan, BMBCh(Oxon)</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duchess of Kent Children's Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>3818752</PMID>
  </reference>
  <reference>
    <citation>Taylor 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.</citation>
    <PMID>24109916</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 2, 2021</last_update_submitted>
  <last_update_submitted_qc>October 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Kenny Kwan</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cervical Myelopathy</keyword>
  <keyword>sEMG</keyword>
  <keyword>Motion capture analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Diseases</mesh_term>
    <mesh_term>Bone Marrow Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03304236
org study id: UW 17-174
nct id: NCT03304236
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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 &lt;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.
observational model: Cohort
time perspective: Prospective
measure: Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis
time frame: 1 year
description: Objective quantification of the hand movement during grip and release test using sEMG and motion capture analysis
measure: Correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis
time frame: 1 year
description: To correlate the clinical severity of myelopathy with different patterns of hand movement using sEMG and motion capture analysis
measure: Correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis
time frame: 1 year
description: To correlate the radiological level of myelopathy involvement with different patterns of hand movement using sEMG and motion capture analysis
measure: Devise a new severity score based on different patterns of hand movement using sEMG and motion capture analysis
time frame: 1 year
description: To devise a new severity score based on different patterns of hand movement nursing sEMG and motion capture analysis
arm group label: Myelopathy hand
description: 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).
intervention type: Device
intervention name: Myelopathy Hand
description: 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)
arm group label: Myelopathy hand
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr Kenny Kwan, BMBCh(Oxon)
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
citation: 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.
citation: 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.
PMID: 3818752
citation: Taylor 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.
PMID: 24109916
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Kenny Kwan
investigator title: Clinical Assistant Professor
mesh term: Spinal Cord Diseases
mesh term: Bone Marrow Diseases
sharing ipd: No