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RecruitingNCT05910593Updated Mar 28, 2024

Establishing the Validity and Reliability of a Dexterity Assessment Tool

An observational study in Myelopathy Cervical, Cervical Spondylosis and Spinal Cord Compression, sponsored by Western University, Canada. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Western University, Canada · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
102
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Every year, thousands of Canadians are diagnosed with degenerative cervical myelopathy (DCM), a form of non-traumatic injury caused by spinal cord compression in the neck. While DCM causes a range of symptoms, one of the most disabling is loss of hand dexterity. Surgical decompression is standard treatment for DCM, but reduced dexterity often remains.

The investigators have developed a portable, easy-to-use dexterity assessment tool for measuring hand dexterity. Hand function is often assessed using tools incapable of measuring subtle changes in function, limiting a clinician's ability to monitor progression of or recovery from a disease over time. The hope is that if subtle changes in function are identified early, leading to an early DCM diagnosis and treatment, this may prevent patients from experiencing a greater loss of hand function.

The goals of this study are to determine the relationship between dexterity and myelopathy severity, as well as to establish the validity and reliability of the dexterity tool. This will be done by assessing dexterity using the dexterity tool in DCM patients (to determine the relationship between disease severity and dexterity, and measure validity) and healthy participants (to establish reliability).

02

Conditions studied

  • Myelopathy Cervical
  • Cervical Spondylosis
  • Spinal Cord Compression
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cervical myelopathy patients will be recruited from a neurosurgery clinic.

Healthy participants will be recruited from individuals who accompany patients to the neurosurgery clinic, in an effort to recruit participants of a similar age to the patient participants.

Inclusion criteria

  • Has been diagnosed with DCM
  • Are between the ages of 35 and 75 years
  • Has no other neurological disorder Inclusion criteria for healthy participants
  • Are between the ages of 35 and 75 years
  • Has no neurological disorder

Exclusion criteria

Exclusion criteria for all participants:

  • Does not fluently speak and read English
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
102 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient

    Patients diagnosed with degenerative cervical myelopathy; will have dexterity measured once with dexterity tool being tested.

    Diagnostic Test: Dexterity Assessment Tool

  • Healthy

    Healthy volunteers will have their dexterity measured at two time points to perform reliability analysis.

    Diagnostic Test: Dexterity Assessment Tool

Interventions

  • Diagnostic testDexterity Assessment Tool

    Measures finger dexterity using pressure sensor pads.

05

What researchers measure

Primary outcomes

  1. Dexterity measurements using the Dexterity Assessment Tool in patients with cervical myelopathy

    It is anticipated that disease severity will be defined based on the dexterity assessment tool

    Time frame: Dexterity will be assessed at one time point, when the participant is recruited

  2. Correlation between the Dexterity Assessment Tool and the GRASSP-M tool (Graded Redefined Assessment of Strength, Sensation and Prehension-Myelopathy)

    Concurrent validity will be measured by correlating the Dexterity Assessment Tool with another validated tool, the GRASSP-M

    Time frame: Dexterity will be assessed with both tools at one time point, when the participant is recruited

  3. Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure inter-rater reliability

    Inter-rater reliability will be assessed by measuring dexterity in healthy participants with two testers administering the tool one hour apart, and correlating the values from the two testers.

    Time frame: Dexterity will be assessed in healthy participants at one time point, when the participant is recruited.

  4. Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure test-retest reliability

    Test-retest reliability will be assessed by measuring dexterity in healthy participants at two time points, one week apart. The data from the two time points will be correlated to determine reliability.

    Time frame: Dexterity well be assessed in healthy participants at two time points, once when the participant is recruited, and once one week later.

06

Study locations

1 of 1 sites recruiting
  • LHSC - University Hospital
    London, Ontario N6A 5A5, Canada
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05910593
Lead sponsor
Western University, Canada
Responsible party
Sponsor
First posted
Jun 20, 2023
Start date
Jun 1, 2023
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 28, 2024

Study contacts

Sarah Detombe, PhD
Contact
sarah.detombe@lhsc.on.ca
5196858500 ext. 35456

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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