Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-28 @ 1:05 AM
Study NCT ID:
NCT05910593
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing the Validity and Reliability of a Dexterity Assessment Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'It is anticipated that disease severity will be defined based on the dexterity assessment tool'}, {'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', 'description': 'Concurrent validity will be measured by correlating the Dexterity Assessment Tool with another validated tool, the GRASSP-M'}, {'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.', 'description': '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.'}, {'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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelopathy Cervical', 'Cervical Spondylosis', 'Spinal Cord Compression']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cervical myelopathy patients will be recruited from a neurosurgery clinic.\n\nHealthy 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for patient participants\n\n* Has been diagnosed with DCM\n* Are between the ages of 35 and 75 years\n* Has no other neurological disorder Inclusion criteria for healthy participants\n* Are between the ages of 35 and 75 years\n* Has no neurological disorder\n\nExclusion criteria for all participants:\n\n• Does not fluently speak and read English'}, 'identificationModule': {'nctId': 'NCT05910593', 'briefTitle': 'Establishing the Validity and Reliability of a Dexterity Assessment Tool', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Establishing the Validity and Reliability of a Dexterity Assessment Tool in DCM and Healthy Populations', 'orgStudyIdInfo': {'id': '123310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patients diagnosed with degenerative cervical myelopathy; will have dexterity measured once with dexterity tool being tested.', 'interventionNames': ['Diagnostic Test: Dexterity Assessment Tool']}, {'label': 'Healthy', 'description': 'Healthy volunteers will have their dexterity measured at two time points to perform reliability analysis.', 'interventionNames': ['Diagnostic Test: Dexterity Assessment Tool']}], 'interventions': [{'name': 'Dexterity Assessment Tool', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measures finger dexterity using pressure sensor pads.', 'armGroupLabels': ['Healthy', 'Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sarah Detombe', 'role': 'CONTACT', 'email': 'sarah.detombe@lhsc.on.ca', 'phone': '5196858500', 'phoneExt': '35456'}], 'facility': 'LHSC - University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Sarah Detombe, PhD', 'role': 'CONTACT', 'email': 'sarah.detombe@lhsc.on.ca', 'phone': '5196858500', 'phoneExt': '35456'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}