NCT04498806

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Aug 2018Aug 2027

Study Start

First participant enrolled

August 13, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 17, 2026

Status Verified

March 1, 2026

Enrollment Period

9 years

First QC Date

July 18, 2020

Last Update Submit

April 14, 2026

Conditions

Cervical Myelopathy

Keywords

cervical myelopathysurgical decompressionactivity monitorsFitbitphysical functionsteps

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: Fitbit

Interventions

FitbitOTHER

The Fitbit device monitors daily activity as a measure of physical function.

Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • Ryan Spiker, M.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 18, 2020

First Posted

August 4, 2020

Study Start

August 13, 2018

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 17, 2026

Record last verified: 2026-03

Locations

US(1)