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Completed

NCT Number: NCT04379921

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

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.

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Key information

Conditions

Spine Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis Spine Degeneration Spine Fusion Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Hospital

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apple Watch and App

Device

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.

Primary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Patient Satisfaction With Their Spine Care

    Time frame: 6 weeks post-operatively

    Reported as the number of participants, by response category.

  14. Patient Satisfaction With Their Spine Care

    Time frame: 3 months post-operatively

    Reported as the number of participants, by response category.

  15. Patient Satisfaction With Their Spine Care

    Time frame: 6 months post-operatively

    Reported as the number of participants, by response category.

  16. Patient Satisfaction With Their Spine Care

    Time frame: 12 months post-operatively

    Reported as the number of participants, by response category.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Stryker Nordic

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 8, 2020
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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