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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of Fitbit devices for monitoring activity in patients with spinal cord disease?

While there is no direct evidence for Fitbit devices, research shows that wearable activity trackers, like the Apple Watch, can objectively measure physical activity in people with spinal cord injury, which may help manage long-term complications. ^{1 2 3 4 5}

Is using Fitbit devices safe for people with chronic health conditions?

Fitbit devices are generally considered safe for use in humans, including children and adolescents with chronic health conditions, as they are non-invasive and designed for consumer use. ^{1 2 5 6 7}

How does the activity monitoring treatment for spinal cord disease differ from other treatments?

This treatment is unique because it uses wearable activity trackers, like the Apple Watch, to objectively measure physical activity in people with spinal cord disease, especially those using wheelchairs. Unlike traditional methods that rely on interviews, this approach provides real-time data and specific measures for wheelchair users, offering a more accurate and personalized assessment of physical activity. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Ryan Spiker, M.D.

Principal Investigator

University of Utah

Eligibility Criteria

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.

Any restrictions on activities before the injury occurred.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of wearable sensor dynamics on physical activity estimates: A comparison between SCI vs. healthy individuals. [2020]

3. England pubmed.ncbi.nlm.nih.gov

In-lab versus at-home activity recognition in ambulatory subjects with incomplete spinal cord injury. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Step Activity Monitor: accuracy and test-retest reliability in persons with incomplete spinal cord injury. [2022]

5. England 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). [2021]

6. China pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Accuracy of Apple Watch fitness tracker for wheelchair use varies according to movement frequency and task. [2021]