Cervical MyelopathyNCT04498806
Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy
A study testing Fitbit in people with Cervical Myelopathy, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- Fitbit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable or unwilling to comply with study protocol
- Known injuries or compounding disability
- Prior-to-injury activity limitations
- Inability to ambulate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Myelopathy
- Being tested
- Fitbit
- Keywords
- cervical myelopathy, surgical decompression, activity monitors, Fitbit, physical function, steps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitOther
The Fitbit device monitors daily activity as a measure of physical function.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pre-op appointment, patient will receive Fitbit device to track physical activity. Receives: Other: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Follow Up Visit at 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start13 Aug 2018
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Spiker, University of Utah
- Investigators
- Ryan Spiker, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498806
- Sponsor's protocol ID
- 113995
- Status last verified
- Mar 2026
- First submitted
- 18 Jul 2020
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy With Surgical Decompression
- ClinicalTrials.gov ID
- NCT04498806
- Acronym / sponsor ID
- 113995
- Conditions
- Cervical Myelopathy
- Keywords
- cervical myelopathy, surgical decompression, activity monitors, Fitbit, physical function, steps
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Aug 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: FitbitPre-op appointment, patient will receive Fitbit device to track physical activity. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 +
- Without known injuries or compounding disability
- Without prior-to-injury activity limitations
- Moderate to severe degenerative cervical pathology
- Undergoing decompression surgery
Key exclusion criteria (4 listed)
- Unable or unwilling to comply with study protocol
- Known injuries or compounding disability
- Prior-to-injury activity limitations
- Inability to ambulate
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 |
|---|---|---|
| FitbitThe Fitbit device monitors daily activity as a measure of physical function. | Other | Intervention |
Primary outcome
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Time frame: Follow Up Visit at 6-8 weeks
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
Time frame: Follow Up Visit at 3-months
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
Time frame: Follow Up Visit at 6-months
Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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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.
Ryan Spiker, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit in people with Cervical Myelopathy, run by University of Utah at 1 site in United States.
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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level (time frame: Follow Up Visit at 6-8 weeks). The study lists 3 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 17 Apr 2026.