Establishing the Validity and Reliability of a Dexterity Assessment Tool

Cervical Spondylosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910593
• Other study ID #: 123310
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Western University, Canada
• Contact: Sarah Detombe, PhD
• Phone: 5196858500
• Email: sarah.detombe[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spondylosis
• Myelopathy Cervical
• Spinal Cord Compression
• Spinal Cord Diseases
• Spondylosis

Intervention

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

Locations

Country	Name	City	State
Canada	LHSC - University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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.