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Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy

Primary Purpose

Cervical Myelopathy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Myelopathy focused on measuring cervical myelopathy, surgical decompression, activity monitors, Fitbit, physical function, steps

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 +
  • Without known injuries or compounding disability
  • Without prior-to-injury activity limitations
  • Moderate to severe degenerative cervical pathology
  • Undergoing decompression surgery
  • Has a personal smartphone with the capability to download the Fitbit app.

Exclusion Criteria:

  • Unable or unwilling to comply with study protocol
  • Known injuries or compounding disability
  • Prior-to-injury activity limitations
  • Inability to ambulate

Sites / Locations

  • University of Utah Orthopedics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Pre-op appointment, patient will receive Fitbit device to track physical activity.

Outcomes

Primary Outcome Measures

Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2020
Last Updated
August 15, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04498806
Brief Title
Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy
Official Title
Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy With Surgical Decompression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 19.2% of adults, 24.5% 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, numbness/clumsiness 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 questionnaires/functional 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, Odom's 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 patient's 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 (i.e. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Myelopathy
Keywords
cervical myelopathy, surgical decompression, activity monitors, Fitbit, physical function, steps

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Pre-op appointment, patient will receive Fitbit device to track physical activity.
Intervention Type
Other
Intervention Name(s)
Fitbit
Intervention Description
The Fitbit device monitors daily activity as a measure of physical function.
Primary Outcome Measure Information:
Title
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Description
Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
Time Frame
Follow Up Visit at 6-8 weeks
Title
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Description
Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
Time Frame
Follow Up Visit at 3-months
Title
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Description
Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
Time Frame
Follow Up Visit at 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 + Without known injuries or compounding disability Without prior-to-injury activity limitations Moderate to severe degenerative cervical pathology Undergoing decompression surgery Has a personal smartphone with the capability to download the Fitbit app. Exclusion Criteria: Unable or unwilling to comply with study protocol Known injuries or compounding disability Prior-to-injury activity limitations Inability to ambulate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Spiker, M.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopedics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy

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