Establishing the Validity and Reliability of a Dexterity Assessment Tool

NCT ID: NCT05910593

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Myelopathy Cervical Cervical Spondylosis Spinal Cord Compression

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient

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

Dexterity Assessment Tool

Intervention Type DIAGNOSTIC_TEST

Measures finger dexterity using pressure sensor pads.

Healthy

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

Dexterity Assessment Tool

Intervention Type DIAGNOSTIC_TEST

Measures finger dexterity using pressure sensor pads.

Interventions

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Dexterity Assessment Tool

Measures finger dexterity using pressure sensor pads.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

• Does not fluently speak and read English
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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LHSC - University Hospital

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sarah Detombe, PhD

Role: CONTACT

5196858500 ext. 35456

Facility Contacts

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Sarah Detombe

Role: primary

5196858500 ext. 35456

Other Identifiers

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123310

Identifier Type: -

Identifier Source: org_study_id

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