Myelopathy CervicalNCT05910593
Establishing the Validity and Reliability of a Dexterity Assessment Tool
An observational study of Myelopathy Cervical and Cervical Spondylosis, run by Western University, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelopathy Cervical, Cervical Spondylosis, Spinal Cord Compression
- What is being tested?
- Dexterity Assessment Tool
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Does not fluently speak and read English
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
LHSC - University Hospital
London, Ontario, N6A 5A5
Sarah Detombe, 5196858500 ext. 35456, sarah.detombe@lhsc.on.ca
About this study
Official title: 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).
- Being tested
- Dexterity Assessment Tool
- Medical subject headings
- Spondylosis, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexterity Assessment ToolDiagnostic test
Measures finger dexterity using pressure sensor pads.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients diagnosed with degenerative cervical myelopathy; will have dexterity measured once with dexterity tool being tested. Receives: Diagnostic Test: Dexterity Assessment Tool | |
| Healthy | Healthy volunteers will have their dexterity measured at two time points to perform reliability analysis. Receives: Diagnostic Test: Dexterity Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Dexterity well be assessed in healthy participants at two time points, once when the participant is recruited, and once one week later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelopathy CervicalStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910593
- Sponsor's protocol ID
- 123310
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Validity and Reliability of a Dexterity Assessment Tool in DCM and Healthy Populations
- ClinicalTrials.gov ID
- NCT05910593
- Acronym / sponsor ID
- 123310
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Diagnostic Test: Dexterity Assessment ToolPatients diagnosed with degenerative cervical myelopathy; will have dexterity measured once with dexterity tool being tested. |
| Healthy | – | Diagnostic Test: Dexterity Assessment ToolHealthy volunteers will have their dexterity measured at two time points to perform reliability analysis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Does not fluently speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexterity Assessment ToolMeasures finger dexterity using pressure sensor pads. | Diagnostic test | Healthy, Patient |
Primary outcome
Dexterity measurements using the Dexterity Assessment Tool in patients with cervical myelopathy
Time frame: Dexterity will be assessed at one time point, when the participant is recruited
It is anticipated that disease severity will be defined based on the dexterity assessment tool
Correlation between the Dexterity Assessment Tool and the GRASSP-M tool (Graded Redefined Assessment of Strength, Sensation and Prehension-Myelopathy)
Time frame: Dexterity will be assessed with both tools at one time point, when the participant is recruited
Concurrent validity will be measured by correlating the Dexterity Assessment Tool with another validated tool, the GRASSP-M
Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure inter-rater reliability
Time frame: Dexterity will be assessed in healthy participants at one time point, when the participant is recruited.
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.
Correlation of dexterity measurements in healthy participants using the Dexterity Assessment Tool to measure test-retest reliability
Time frame: Dexterity well be assessed in healthy participants at two time points, once when the participant is recruited, and once one week later.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelopathy Cervical and Cervical Spondylosis, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Detombe, PhD (5196858500 ext. 35456, sarah.detombe@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexterity measurements using the Dexterity Assessment Tool in patients with cervical myelopathy (time frame: Dexterity will be assessed at one time point, when the participant is recruited). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.