Activity Monitoring for Spinal Cord Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Known injuries, Compounding disability, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare how well a Fitbit tracks physical activity against traditional question-based methods for individuals with degenerative cervical myelopathy, a condition affecting the spine. Participants will wear a Fitbit before and after their decompression surgery to monitor activity levels. The goal is to better understand how this condition impacts daily life and to find simpler ways to track its progress. Suitable candidates for this trial include those undergoing decompression surgery, who have a smartphone for the Fitbit app, and who have not experienced prior activity limitations or additional disabilities. As an unphased trial, this study offers participants the chance to contribute to innovative research that could simplify tracking and enhance understanding of their condition.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Fitbit devices are safe for monitoring activity in spinal cord disease patients?

Research shows that using a Fitbit is generally safe for tracking physical activity. Studies involving individuals with lumbar stenosis, a spine condition, have used Fitbit devices to monitor activity without safety concerns. Additionally, studies with wheelchair users who have spinal cord injuries have focused on tracking heart rate and activity levels, reporting no major safety issues.

Fitbits are commonly used in research and daily life, indicating they are well-tolerated. Worn like a watch, they are non-invasive and do not interfere with the body, making them a low-risk option for monitoring activity in people with spinal cord issues. Overall, evidence supports the safety of Fitbit devices for tracking physical activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Fitbits for spinal cord disease management because they offer a new way to monitor physical activity in real-time. Unlike traditional methods that might rely on occasional check-ups or subjective patient reports, Fitbits provide continuous, objective data on movement and activity levels. This can help doctors better understand a patient's condition and tailor their treatment plans more effectively. By using wearable technology, there's potential for more personalized care and improved outcomes for patients with spinal cord disease.

What evidence suggests that using Fitbit devices is effective for monitoring degenerative cervical myelopathy?

Research has shown that Fitbits effectively track physical activity and heart rate, even for individuals with spinal cord injuries. One study found that the Fitbit Charge 2 accurately measures heart rate using a method called PPG, providing dependable readings. Another study found that most people with spinal cord injuries could wear the Fitbit regularly over weeks or months, demonstrating its practicality for daily use. In this trial, participants will receive a Fitbit device to track their physical activity. Fitbits have also been used in various health studies, including those focused on spinal cord injuries, to monitor physical activity. Overall, using a Fitbit can effectively track activity levels, which may be particularly beneficial for conditions like degenerative cervical myelopathy. ^{4 5 6 7 8}

Who Is on the Research Team?

Ryan Spiker, M.D.

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe degenerative cervical myelopathy who are about to have decompression surgery. Participants need a smartphone capable of downloading the Fitbit app and must not have other injuries, disabilities, or activity limitations prior to their condition.

Inclusion Criteria

You do not have any existing injuries or disabilities that could make your condition worse.

I am scheduled for surgery to relieve pressure in a body part.

I have moderate to severe neck spine issues.

Exclusion Criteria

You have existing injuries or disabilities that could make participating in the study more difficult.

I am willing and able to follow the study rules.

I cannot walk on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive a Fitbit device to track physical activity before surgical intervention

4 weeks

1 visit (in-person)

Surgical Treatment

Participants undergo surgical decompression for degenerative cervical myelopathy

1 week

1 visit (in-person)

Post-operative Monitoring

Participants' physical activity is monitored using Fitbit to assess recovery and surgical efficacy

6 months

Follow-up visit at 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit

Trial Overview The study aims to see if using a Fitbit activity monitor can give us as good or better information about physical function in patients with cervical myelopathy compared to standard question-based measures before and after they receive treatment.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

The Apple Watch Series 4 shows a significant improvement in measuring wheelchair pushes for users with spinal cord injury, with a mean absolute percent error (MAPE) of 9.20%, indicating it can effectively track physical activity in this population.

In comparison to the older Series 1, the Series 4 provides more accurate data, making it a promising tool for objectively measuring physical activity in wheelchair users, although it tends to overestimate the number of pushes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. Benning, NH., Knaup, P., Rupp, R.[2022]

Fitbit devices are feasible for monitoring physical activity in children and adolescents with chronic health conditions, potentially improving their overall wellbeing and physical health.

However, the accuracy of Fitbit data is not sufficiently supported by evidence, suggesting that while they can be useful for general health tracking, medical-grade technologies are recommended for collecting precise health data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Fitbit devices among children and adolescents with chronic health conditions: a scoping review. Kasparian, AM., Badawy, SM.[2022]

A study involving 19 manual wheelchair users with chronic spinal cord injury found that accelerometers and self-reported assessments of physical activity showed low agreement, indicating that they measure different aspects of physical activity.

While accelerometers were effective in detecting brief or intermittent activities, the self-report measure was better for capturing activities like resistance training and wheeling on inclines, suggesting that using both methods together may provide a more comprehensive view of physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity measurement in people with spinal cord injury: comparison of accelerometry and self-report (the Physical Activity Recall Assessment for People with Spinal Cord Injury). Ma, JK., McCracken, LA., Voss, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811691/

Accuracy of Heart Rate Measurement by the Fitbit Charge ... The objective of this study is to investigate the HR accuracy measured with the PPG technique with a Fitbit Charge 2 (Fitbit Inc) in wheelchair users with SCI.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35044306/

Accuracy of Heart Rate Measurement by the Fitbit Charge ... The objective of this study is to investigate the HR accuracy measured with the PPG technique with a Fitbit Charge 2 (Fitbit Inc) in wheelchair users with SCI.

3. researchgate.net researchgate.net/publication/327584718_Is_Fitbit_Charge_2_a_feasible_instrument_to_monitor_daily_physical_activity_and_handbike_training_in_persons_with_spinal_cord_injury_A_pilot_study

Is Fitbit Charge 2 a feasible instrument to monitor daily ... However, Maijers et al. (2018) found that five of six individuals with SCIs had high compliance of wearing the Fitbit Charge 2 for multiple weeks or even months ...

4. mhealth.jmir.org mhealth.jmir.org/2025/1/e46149

Using Wear Time for the Analysis of Consumer-Grade ... The CareQOL JITAI project that used Fitbit wearable sensors across hematopoietic cell transplantation, spinal cord injury, and traumatic brain ...

5. researchgate.net researchgate.net/publication/357955815_Accuracy_of_Heart_Rate_Measurement_by_the_Fitbit_Charge_2_During_Wheelchair_Activities_in_People_With_Spinal_Cord_Injury_Instrument_Validation_Study_Preprint

Accuracy of Heart Rate Measurement by the Fitbit Charge ... Accuracy of Heart Rate Measurement by the Fitbit Charge 2 During Wheelchair Activities in People With Spinal Cord Injury: Instrument Validation Study (Preprint).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11109865/

Accuracy of the Apple Watch Series 4 and Fitbit Versa for ... Wheelchair users with a spinal cord injury (SCI) have a 14% to 27% lower REE due to reduced fat-free mass and sympathetic nervous system ...

7. vertosmed.com vertosmed.com/fitbit-trial-for-lumbar-stenosis/

Fitbit Trial for Lumbar Stenosis Ivanhoe Newswire discusses how Vertos Medical is using Fitbits to monitor patient activity following the Mild® Procedure to treat lumbar ...

8. fitabase.com fitabase.com/research-library/

Fitbit Research Library The Fitbit Research Library by Fitabase is the most comprehensive resource for published research using Fitbit devices.