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Apple Watch Tracking for Spinal Surgery Recovery

N/A

Recruiting

Led By Corinna Zygourakis, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing elective spine surgery by attending physicians at Stanford University

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-6 weeks pre-operatively; 4-6 weeks, 3 months, 6 months, and 12 months post-operatively

Awards & highlights

Study Summary

This trial is testing whether the Apple Watch can help improve postoperative care for spine surgery patients by allowing them to track their own activity and discuss it with their surgeon.

Who is the study for?

This trial is for English-speaking individuals who are scheduled for elective spine surgery at Stanford University and own an iPhone. It's not open to patients with tumors, spine trauma, or infections.Check my eligibility

What is being tested?

The study tests the use of the Apple Watch and a companion app to track patient activity before and after elective spine surgery. The goal is to see if this technology can help improve patient empowerment, satisfaction, and self-reported outcomes.See study design

What are the potential side effects?

Since this trial involves using an Apple Watch and app rather than medication or invasive procedures, traditional side effects aren't expected. However, there may be privacy concerns regarding personal data collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for spine surgery at Stanford University by its attending physicians.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-6 weeks pre-operatively; 4-6 weeks, 3 months, 6 months, and 12 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-6 weeks pre-operatively; 4-6 weeks, 3 months, 6 months, and 12 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-6 weeks pre-operatively; 4-6 weeks, 3 months, 6 months, and 12 months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Objective Outcome Measures (Steps, Distance Travelled, etc from Apple Watch) Before and After Surgery

Correlation between Objective Patient Measures (Steps, Distance Travelled, etc from Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI, VAS)

Patient Compliance with Wearing Apple Watch

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Apple Watch and AppExperimental Treatment1 Intervention

Participants will receive standard care, and an Apple Watch to record activity through the App.

Group II: ControlActive Control1 Intervention

Participants will receive standard care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stryker NordicIndustry Sponsor

32 Previous Clinical Trials

3,895 Total Patients Enrolled

1 Trials studying Surgery

40 Patients Enrolled for Surgery

Stanford UniversityLead Sponsor

2,383 Previous Clinical Trials

17,333,654 Total Patients Enrolled

6 Trials studying Surgery

777 Patients Enrolled for Surgery

Corinna Zygourakis, MD4.229 ReviewsPrincipal Investigator - Department of Neurosurgery at Stanford University

Stanford University

5Patient Review

Thank you, Dr. Zygouraskis!

Media Library

Apple Watch and App Clinical Trial Eligibility Overview. Trial Name: NCT04379921 — N/A

Surgery Research Study Groups: Apple Watch and App, Control

Surgery Clinical Trial 2023: Apple Watch and App Highlights & Side Effects. Trial Name: NCT04379921 — N/A

Apple Watch and App 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379921 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for individuals to join this research endeavor?

"According to clinicaltrials.gov, this medical study still requires research participants. The original post was published on September 1st 2020 and the latest update occurred on June 3rd 2021."

Answered by AI

What is the total enrollment of participants for this experiment?

"Affirmative, clinicaltrials.gov's information reveals that this medical study is currently recruiting patients. First posted on September 1st 2020 and recently updated on June 3rd 2021, the trial aims to enroll 200 participants from a single location."

Answered by AI

Recent research and studies

NeurosurgeryJournal

Trends for Spine Surgery for the Elderly

O'Lynnger, Thomas M., Scott L. Zuckerman, Peter J. Morone, Michael C. Dewan, Raul A. Vasquez-Castellanos, and Joseph S. Cheng. 2015. “Trends for Spine Surgery for the Elderly”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/neu.0000000000000945.

Surgical Neurology InternationalJournal

A Review Article on the Benefits of Early Mobilization Following Spinal Surgery and Other Medical/surgical Procedures

Epstein, NancyE. 2014. “A Review Article on the Benefits of Early Mobilization Following Spinal Surgery and Other Medical/surgical Procedures”. Surgical Neurology International. Scientific Scholar. doi:10.4103/2152-7806.130674.

JMIR Formative ResearchJournal

Measuring Free-living Physical Activity with Three Commercially Available Activity Monitors for Telemonitoring Purposes: Validation Study

Breteler, Martine JM, Joris H Janssen, Wilko Spiering, Cor J Kalkman, Wouter W van Solinge, and Daan AJ Dohmen. 2019. “Measuring Free-living Physical Activity with Three Commercially Available Activity Monitors for Telemonitoring Purposes: Validation Study”. JMIR Formative Research. JMIR Publications Inc.. doi:10.2196/11489.

Journal of General Internal MedicineJournal