NCT03304236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

September 27, 2017

Last Update Submit

October 2, 2021

Conditions

Cervical Myelopathy

Keywords

Cervical MyelopathysEMGMotion capture analysis

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (3)

  • 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

    1 year

  • Devise a new severity score based on different patterns of hand movement using sEMG and motion capture analysis

    1 year

Study Arms (1)

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

Interventions

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)

Myelopathy hand

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

Location

Related Publications (3)

  • 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.

    BACKGROUND

  • 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: 3818752BACKGROUND

  • 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: 24109916BACKGROUND

Study Officials

  • Dr Kenny Kwan, BMBCh(Oxon)

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 6, 2017

Study Start

July 1, 2017

Primary Completion

March 31, 2019

Study Completion

June 30, 2020

Last Updated

October 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)