Clinical trial NCT05910593: Establishing the Validity and Reliability of a Dexterity Assessment Tool
Official title: Establishing the Validity and Reliability of a Dexterity Assessment Tool in DCM and Healthy Populations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelopathy Cervical
Cervical Spondylosis
Spinal Cord Compression
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Dexterity measurements using the Dexterity Assessment Tool in patients with cervical myelopathy
timeFrame: Dexterity will be assessed at one time point, when the participant is recruited
measure: Correlation between the Dexterity Assessment Tool and the GRASSP-M tool (Graded Redefined Assessment of Strength, Sensation and Prehension-Myelopathy)
timeFrame: Dexterity will be assessed with both tools at one time point, when the participant is recruited
measure: Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure inter-rater reliability
timeFrame: Dexterity will be assessed in healthy participants at one time point, when the participant is recruited.
measure: Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure test-retest reliability
timeFrame: Dexterity well be assessed in healthy participants at two time points, once when the participant is recruited, and once one week later.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
Study officials:
References: