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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cervical Myelopathy
• Intervention / Treatment: Other: Fitbit

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Pre-op appointment, patient will receive Fitbit device to track physical activity.	Other: Fitbit; The Fitbit device monitors daily activity as a measure of physical function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Follow Up Visit at 6-8 weeks
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.	Follow Up Visit at 3-months
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.	Follow Up Visit at 6-months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Ryan Spiker, M.D., University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: physical function; Fitbit; cervical myelopathy; surgical decompression; activity monitors; steps
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: 113995

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No