Establishing the Validity and Reliability of a Dexterity Assessment Tool

Sponsor
Western University, Canada (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05910593
Collaborator
(none)
102
18

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Dexterity Assessment Tool

Study Design

Study Type:
Observational
Anticipated Enrollment :
102 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Establishing the Validity and Reliability of a Dexterity Assessment Tool in DCM and Healthy Populations
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Patient

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

Diagnostic Test: Dexterity Assessment Tool
Measures finger dexterity using pressure sensor pads.

Healthy

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

Diagnostic Test: Dexterity Assessment Tool
Measures finger dexterity using pressure sensor pads.

Outcome Measures

Primary Outcome Measures

  1. Dexterity measurements using the Dexterity Assessment Tool in patients with cervical myelopathy [Dexterity will be assessed at one time point, when the participant is recruited]

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

  2. Correlation between the Dexterity Assessment Tool and the GRASSP-M tool (Graded Redefined Assessment of Strength, Sensation and Prehension-Myelopathy) [Dexterity will be assessed with both tools at one time point, when the participant is recruited]

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

  3. Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure inter-rater reliability [Dexterity will be assessed in healthy participants at one time point, when the participant is recruited.]

    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.

  4. Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure test-retest reliability [Dexterity well be assessed in healthy participants at two time points, once when the participant is recruited, and once one week later.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion criteria for patient participants

  • 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 for all participants:

• Does not fluently speak and read English

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Western University, Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Western University, Canada
ClinicalTrials.gov Identifier:
NCT05910593
Other Study ID Numbers:
  • 123310
First Posted:
Jun 20, 2023
Last Update Posted:
Jun 20, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 20, 2023