Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
NCT ID: NCT04379921
Last Updated: 2025-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
255 participants
INTERVENTIONAL
2020-09-01
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Participants will receive standard care.
No interventions assigned to this group
Apple Watch and App
Participants will receive standard care, and an Apple Watch to record activity through the App.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Undergoing elective spine surgery by attending physicians at Stanford University.
* Own iPhone
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Stryker Nordic
INDUSTRY
Stanford University
OTHER
Responsible Party
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Corinna Zygourakis
Assistant Professor of Neurosurgery
Principal Investigators
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Corinna Zygourakis, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery at Stanford University
Locations
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Stanford University Hospital
Palo Alto, California, United States
Countries
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References
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Bernstein DN, Brodell D, Li Y, Rubery PT, Mesfin A. Impact of the Economic Downturn on Elective Lumbar Spine Surgery in the United States: A National Trend Analysis, 2003 to 2013. Global Spine J. 2017 May;7(3):213-219. doi: 10.1177/2192568217694151. Epub 2017 Apr 6.
Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.
O'Lynnger TM, Zuckerman SL, Morone PJ, Dewan MC, Vasquez-Castellanos RA, Cheng JS. Trends for Spine Surgery for the Elderly: Implications for Access to Healthcare in North America. Neurosurgery. 2015 Oct;77 Suppl 4:S136-41. doi: 10.1227/NEU.0000000000000945.
Parker SL, Chotai S, Devin CJ, Tetreault L, Mroz TE, Brodke DS, Fehlings MG, McGirt MJ. Bending the Cost Curve-Establishing Value in Spine Surgery. Neurosurgery. 2017 Mar 1;80(3S):S61-S69. doi: 10.1093/neuros/nyw081.
Epstein NE. A review article on the benefits of early mobilization following spinal surgery and other medical/surgical procedures. Surg Neurol Int. 2014 Apr 16;5(Suppl 3):S66-73. doi: 10.4103/2152-7806.130674. eCollection 2014.
Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.
Lu TC, Fu CM, Ma MH, Fang CC, Turner AM. Healthcare Applications of Smart Watches. A Systematic Review. Appl Clin Inform. 2016 Sep 14;7(3):850-69. doi: 10.4338/ACI-2016-03-R-0042.
Reeder B, David A. Health at hand: A systematic review of smart watch uses for health and wellness. J Biomed Inform. 2016 Oct;63:269-276. doi: 10.1016/j.jbi.2016.09.001. Epub 2016 Sep 6.
Henriksen A, Haugen Mikalsen M, Woldaregay AZ, Muzny M, Hartvigsen G, Hopstock LA, Grimsgaard S. Using Fitness Trackers and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer Wrist-Worn Wearables. J Med Internet Res. 2018 Mar 22;20(3):e110. doi: 10.2196/jmir.9157.
Mobbs RJ, Phan K, Maharaj M, Rao PJ. Physical Activity Measured with Accelerometer and Self-Rated Disability in Lumbar Spine Surgery: A Prospective Study. Global Spine J. 2016 Aug;6(5):459-64. doi: 10.1055/s-0035-1565259. Epub 2015 Oct 13.
Phan K, Mobbs RJ. Long-Term Objective Physical Activity Measurements using a Wireless Accelerometer Following Minimally Invasive Transforaminal Interbody Fusion Surgery. Asian Spine J. 2016 Apr;10(2):366-9. doi: 10.4184/asj.2016.10.2.366. Epub 2016 Apr 15.
Breteler MJ, Janssen JH, Spiering W, Kalkman CJ, van Solinge WW, Dohmen DA. Measuring Free-Living Physical Activity With Three Commercially Available Activity Monitors for Telemonitoring Purposes: Validation Study. JMIR Form Res. 2019 Apr 24;3(2):e11489. doi: 10.2196/11489.
Veerabhadrappa P, Moran MD, Renninger MD, Rhudy MB, Dreisbach SB, Gift KM. Tracking Steps on Apple Watch at Different Walking Speeds. J Gen Intern Med. 2018 Jun;33(6):795-796. doi: 10.1007/s11606-018-4332-y.
Xie J, Wen D, Liang L, Jia Y, Gao L, Lei J. Evaluating the Validity of Current Mainstream Wearable Devices in Fitness Tracking Under Various Physical Activities: Comparative Study. JMIR Mhealth Uhealth. 2018 Apr 12;6(4):e94. doi: 10.2196/mhealth.9754.
Maldaner N, Tang M, Fatemi P, Leung C, Desai A, Tomkins-Lane C, Zygourakis C. Standardizing Physical Activity Monitoring in Patients With Degenerative Lumbar Disorders. Neurosurgery. 2024 Apr 1;94(4):788-796. doi: 10.1227/neu.0000000000002755. Epub 2023 Nov 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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2017 Profile of Older Americans
Global Smartwatch Vendor Market Share
Other Identifiers
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52367
Identifier Type: -
Identifier Source: org_study_id