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Activity Monitoring for Spinal Cord Disease
N/A
Waitlist Available
Led By Ryan Spiker, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing decompression surgery
Moderate to severe degenerative cervical pathology
Must not have
Unable or unwilling to comply with study protocol
Inability to ambulate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow up visit at 6-months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare activity monitor results with standard of care question-based outcome measures for degenerative cervical myelopathy patients before and after treatment with decompression.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves using an activity monitor like a Fitbit, there aren't direct medical side effects. However, participants may experience discomfort wearing the device or privacy concerns related to data collection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery to relieve pressure in a body part.
Select...
I have moderate to severe neck spine issues.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am willing and able to follow the study rules.
Select...
I cannot walk on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow up visit at 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up visit at 6-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Pre-op appointment, patient will receive Fitbit device to track physical activity.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,586 Total Patients Enrolled
Ryan Spiker, M.D.Principal InvestigatorUniversity of Utah
1 Previous Clinical Trials
608 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have existing injuries or disabilities that could make participating in the study more difficult.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 am 18 years old or older.I have moderate to severe neck spine issues.You did not have any limitations before the injury.I am willing and able to follow the study rules.Any restrictions on activities before the injury occurred.I cannot walk on my own.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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