Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch

December 2, 2025 updated by: Corinna Zygourakis, Stanford University
One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • English-speaking.
  • Undergoing elective spine surgery by attending physicians at Stanford University.
  • Own iPhone

Exclusion Criteria:

  • Patients with spine trauma, tumors, or infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants will receive standard care.
Experimental: Apple Watch and App
Participants will receive standard care, and an Apple Watch to record activity through the App.
Device: Apple Watch and App
Participants in the Apple Watch and App arm will receive an Apple Watch and download an App (NeuroCoach). The Apple Watch and App are used for this study to record patient's mobility information (e.g., step counts, heart rate, stairs climbed, distance traveled) as well as provide an additional platform for patients to complete questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time Frame: 2-6 weeks pre-operatively

Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.

  • Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
  • Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
  • Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
2-6 weeks pre-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time Frame: 4-6 weeks post-operatively

Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.

  • Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
  • Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
  • Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
4-6 weeks post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time Frame: 6 weeks-3 months post-operatively

Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.

  • Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
  • Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
  • Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
6 weeks-3 months post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time Frame: 3-6 months post-operatively

Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.

  • Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
  • Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
  • Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
3-6 months post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time Frame: 6-12 months post-operatively

Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.

  • Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
  • Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
  • Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
  • Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
6-12 months post-operatively
Change in Objective Outcome Measures: Number of Steps After Surgery
Time Frame: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Steps per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
Time Frame: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Meters per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Time Frame: 2-6 weeks pre-operatively
Average hours wear time per day across the outcome measure time frame.
2-6 weeks pre-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Time Frame: 4-6 weeks post-operatively
Average hours wear time per day across the outcome measure time frame.
4-6 weeks post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Time Frame: 6 weeks-3 months post-operatively
Average hours wear time per day across the outcome measure time frame.
6 weeks-3 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Time Frame: 3-6 months post-operatively
Average hours wear time per day across the outcome measure time frame.
3-6 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Time Frame: 6-12 months post-operatively
Average hours wear time per day across the outcome measure time frame.
6-12 months post-operatively
Patient Satisfaction With Their Spine Care
Time Frame: 6 weeks post-operatively
Reported as the number of participants, by response category.
6 weeks post-operatively
Patient Satisfaction With Their Spine Care
Time Frame: 3 months post-operatively
Reported as the number of participants, by response category.
3 months post-operatively
Patient Satisfaction With Their Spine Care
Time Frame: 6 months post-operatively
Reported as the number of participants, by response category.
6 months post-operatively
Patient Satisfaction With Their Spine Care
Time Frame: 12 months post-operatively
Reported as the number of participants, by response category.
12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Stryker Nordic

Investigators

  • Principal Investigator: Corinna Zygourakis, MD, Department of Neurosurgery at Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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