Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498806
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-23
First Post:
2020-07-18
Brief Title:
Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy With Surgical Decompression
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators objective of this research is to compare activity monitor results with standard of care SOC question-based outcome measures for degenerative cervical myelopathy patients before and after treatment with decompression
Understanding of the relationship between activity monitor data and question-based outcome measures in the context of degenerative cervical myelopathy will improve our understanding of the disease and limit the effort to diagnose and monitor it
Understanding of the relationship between activity monitor data and question-based outcome measures in the context of degenerative cervical myelopathy will improve our understanding of the disease and limit the effort to diagnose and monitor it
Detailed Description:
Degenerative cervical myelopathy DCM is the most common cause of spinal dysfunction across the world and a major cause of disability DCM describes a group of conditions that progressively impinge on the spinal cord resulting in functional impairment and a reduced quality of life Degenerative diseases of the spine increase in prevalence with increases in age A cadaver study of 469 adults found cervical stenosis of at least one level in 192 of adults 245 in those older than 50 and 27 of those older than 70 years By 2050 the global population over 60 years of age is expected to approach 2 billion DCM is certainly a prevalent disease in the elderly and will only become more common For these reasons DCM must be addressed thoroughly in research to improve outcomes
Symptoms of afflicted patients often include neck pain numbnessclumsiness in the hands weakness upper and lower extremity motor deficits balance and gait impairment among others Non-surgical treatment has limited efficacy while early surgical treatment is recommended to halt progression initiate recovery and improve symptoms Surgical treatment is widely agreed upon yet measurement of surgical outcomes can be challenging
Traditionally assessment of outcomes has been performed subjectively using questionnairesfunctional assessments These question-based outcome measures are popular due to practicality and ease of administration Examples that have been used in Degenerative Cervical Myelopathy DCM include Neck Disability Index NDI Myelopathy Disability Index MDI Japanese Orthopedic Association JOA European Myelopathy Score EMS Nurick Score Ranawat Score Odoms criteria and Short Form-36 survey SF-36 This introduces incompatibility when comparing studies using different questionnaires In addition to the lack of consensus in a standard questionnaire there are inherent biases in the use of self-reported measures Self-reported questionnaires and objective disability measures do not always agree particularly when recent setbacks distort a patients perception of total improvement Personal evaluation is subject to inherent bias with a disconnect between perception of disability and actual objective performance
Gait disturbance may be the most be the most prominent physical finding in DCM and walking tests have been established as effective objective measures in DCM pre and post-operatively A patients activity level at home provides valuable data on recovery and surgical efficacy yet prior to wearable technology required self-reported data Accelerometers have been used to remedy this problem by measuring activity trends in a quantifiable manner without relying on the subjective response of the patient They have recently been implemented in orthopedic research Investigators have compared self-rated disability with objective accelerometer data in patients suffering from lumbar spinal stenosis LSS and found self-rated disability did not always reflect objective data Some investigators used these methods to objectively measure function after surgical intervention lumbar spinal stenosis decompression Results are promising and require further investigation into the application of this new tool
In summary accelerometers offer longitudinal objective measurement of walking and the ability to look at trends in activity levels Eventually walking measures could be used to monitor patients with mild myelopathy for progression and possibly even be part of a remote screening tool ie a phone tracks walking distance speed number of falls per month and prompts for monthly or quarterly handwriting samples We aim to apply similar concepts of prior investigations to compare accelerometer and question-based outcome data on DCM patients before and after undergoing surgical intervention to determine the most practical and accurate method for outcome measurement By incorporating activity monitor data and looking at relationships between the different measures we will be able to better understand the disease and limit the effort required to diagnose and monitor it
Symptoms of afflicted patients often include neck pain numbnessclumsiness in the hands weakness upper and lower extremity motor deficits balance and gait impairment among others Non-surgical treatment has limited efficacy while early surgical treatment is recommended to halt progression initiate recovery and improve symptoms Surgical treatment is widely agreed upon yet measurement of surgical outcomes can be challenging
Traditionally assessment of outcomes has been performed subjectively using questionnairesfunctional assessments These question-based outcome measures are popular due to practicality and ease of administration Examples that have been used in Degenerative Cervical Myelopathy DCM include Neck Disability Index NDI Myelopathy Disability Index MDI Japanese Orthopedic Association JOA European Myelopathy Score EMS Nurick Score Ranawat Score Odoms criteria and Short Form-36 survey SF-36 This introduces incompatibility when comparing studies using different questionnaires In addition to the lack of consensus in a standard questionnaire there are inherent biases in the use of self-reported measures Self-reported questionnaires and objective disability measures do not always agree particularly when recent setbacks distort a patients perception of total improvement Personal evaluation is subject to inherent bias with a disconnect between perception of disability and actual objective performance
Gait disturbance may be the most be the most prominent physical finding in DCM and walking tests have been established as effective objective measures in DCM pre and post-operatively A patients activity level at home provides valuable data on recovery and surgical efficacy yet prior to wearable technology required self-reported data Accelerometers have been used to remedy this problem by measuring activity trends in a quantifiable manner without relying on the subjective response of the patient They have recently been implemented in orthopedic research Investigators have compared self-rated disability with objective accelerometer data in patients suffering from lumbar spinal stenosis LSS and found self-rated disability did not always reflect objective data Some investigators used these methods to objectively measure function after surgical intervention lumbar spinal stenosis decompression Results are promising and require further investigation into the application of this new tool
In summary accelerometers offer longitudinal objective measurement of walking and the ability to look at trends in activity levels Eventually walking measures could be used to monitor patients with mild myelopathy for progression and possibly even be part of a remote screening tool ie a phone tracks walking distance speed number of falls per month and prompts for monthly or quarterly handwriting samples We aim to apply similar concepts of prior investigations to compare accelerometer and question-based outcome data on DCM patients before and after undergoing surgical intervention to determine the most practical and accurate method for outcome measurement By incorporating activity monitor data and looking at relationships between the different measures we will be able to better understand the disease and limit the effort required to diagnose and monitor it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None