Establishing the Validity and Reliability of a Dexterity Assessment Tool

NCT05910593 | Recruiting

• 1 other identifier: 123310
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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).

Conditions

Myelopathy Cervical; Cervical Spondylosis; Spinal Cord Compression

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

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

Dexterity Assessment Tool DIAGNOSTIC_TEST

Measures finger dexterity using pressure sensor pads.

Healthy; Patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Has been diagnosed with DCM
• Are between the ages of 35 and 75 years
• Are between the ages of 35 and 75 years
• Has no neurological disorder

You may not qualify if:

• Does not fluently speak and read English

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

LHSC - University Hospital

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Spondylosis; Spinal Cord Compression

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Central Study Contacts

Sarah Detombe, PhD

CONTACT

5196858500; sarah.detombe@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 20, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)