Establishing the Validity and Reliability of a Dexterity Assessment Tool

Establishing the Validity and Reliability of a Dexterity Assessment Tool in DCM and Healthy Populations

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).

Study Overview

• Status: Recruiting
• Conditions: Cervical Spondylosis; Myelopathy Cervical; Spinal Cord Compression
• Intervention / Treatment: Diagnostic test: Dexterity Assessment Tool

• Study Type: Observational
• Enrollment (Estimated): 102

Contacts and Locations

• Study Contact: Name: Sarah Detombe, PhD; Phone Number: 35456 5196858500; Email: sarah.detombe@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • LHSC - University Hospital
      • Contact: Sarah Detombe; Phone Number: 35456 5196858500; Email: sarah.detombe@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Dexterity will be assessed at one time point, when the participant is recruited
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	Dexterity will be assessed with both tools at one time point, when the participant is recruited
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.	Dexterity will be assessed in healthy participants at one time point, when the participant is recruited.
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.	Dexterity well be assessed in healthy participants at two time points, once when the participant is recruited, and once one week later.

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Cord Injuries; Spinal Cord Diseases; Spondylosis; Spinal Cord Compression
• Other Study ID Numbers: 123310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No