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NCT05370534 Clinical Trial

Smartphone-Based Markerless Motion Capture for Orthopaedic Clinical Use

Musculoskeletal Diseases or Conditions Clinical Trial

Official title:
Smartphone-Based Markerless Motion Capture for Orthopaedic Clinical Use

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05370534
Other study ID # 274321
Secondary ID GM125503
Status Withdrawn
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 18, 2023

Study information
Verified date February 2023
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators propose to create a markerless smartphone-based MCA application using AR to measure joint motion and gait patterns to address this technology gap for a simple and inexpensive MCA.

Description:

Aim 1 will establish a testable AR-based smartphone app that measures clinically relevant lower-extremity motion components. Existing AR code will be adapted to identify and quantify hip, knee, and ankle range of motion in both the coronal and sagittal planes. Output will be produced directly to the phone display and can also be downloadable. Both single-motion and sequential-motion (gait) measures will be captured. Aim 2 will then compare the app-based MCA to traditional gold standard MCA in healthy volunteers. A dedicated human biomechanics lab with capability for MCA with reflective markers will be utilized to test both MCA methods. Patients will perform a box jump and normal walking gait, and the measurements from both the standard marker-based MCA system and the smartphone markerless MCA system will be statistically compared.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 18, 2023
Est. primary completion date December 18, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria - 18-65 years old - No known spinal pathology - No previous lower extremity surgery - No significant cardiac history Exclusion Criteria - <18 or >65 years old - Known spinal pathology - Previous lower extremity surgery - Significant cardiac history

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (2)
Lead Sponsor Collaborator
University of Arkansas National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (15)

Camp CL, Loushin S, Nezlek S, Fiegen AP, Christoffer D, Kaufman K. Are Wearable Sensors Valid and Reliable for Studying the Baseball Pitching Motion? An Independent Comparison With Marker-Based Motion Capture. Am J Sports Med. 2021 Sep;49(11):3094-3101. doi: 10.1177/03635465211029017. Epub 2021 Aug 2. — View Citation

Di Paolo S, Zaffagnini S, Tosarelli F, Aggio F, Bragonzoni L, Grassi A, Della Villa F. A 2D qualitative movement assessment of a deceleration task detects football players with high knee joint loading. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4032-4040. doi: 10.1007/s00167-021-06709-2. Epub 2021 Sep 4. — View Citation

Kuai S, Guan X, Liu W, Ji R, Xiong J, Wang D, Zhou W. Prediction of the Spinal Musculoskeletal Loadings during Level Walking and Stair Climbing after Two Types of Simulated Interventions in Patients with Lumbar Disc Herniation. J Healthc Eng. 2019 Dec 17;2019:6406813. doi: 10.1155/2019/6406813. eCollection 2019. — View Citation

Kuchen DB, Eichelberger P, Baur H, Rutz E. Long-term follow-up after patellar tendon shortening for flexed knee gait in bilateral spastic cerebral palsy. Gait Posture. 2020 Sep;81:85-90. doi: 10.1016/j.gaitpost.2020.07.003. Epub 2020 Jul 6. — View Citation

McGinley JL, Baker R, Wolfe R, Morris ME. The reliability of three-dimensional kinematic gait measurements: a systematic review. Gait Posture. 2009 Apr;29(3):360-9. doi: 10.1016/j.gaitpost.2008.09.003. Epub 2008 Nov 13. — View Citation

Paloschi D, Bravi M, Schena E, Miccinilli S, Morrone M, Sterzi S, Saccomandi P, Massaroni C. Validation and Assessment of a Posture Measurement System with Magneto-Inertial Measurement Units. Sensors (Basel). 2021 Oct 3;21(19):6610. doi: 10.3390/s21196610. — View Citation

Scano A, Chiavenna A, Malosio M, Molinari Tosatti L, Molteni F. Kinect V2 implementation and testing of the reaching performance scale for motor evaluation of patients with neurological impairment. Med Eng Phys. 2018 Jun;56:54-58. doi: 10.1016/j.medengphy.2018.04.005. Epub 2018 Apr 20. — View Citation

Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419. — View Citation

Tamura H, Tanaka R, Kawanishi H. Reliability of a markerless motion capture system to measure the trunk, hip and knee angle during walking on a flatland and a treadmill. J Biomech. 2020 Aug 26;109:109929. doi: 10.1016/j.jbiomech.2020.109929. Epub 2020 Jul 1. — View Citation

Tanaka R, Takimoto H, Yamasaki T, Higashi A. Validity of time series kinematical data as measured by a markerless motion capture system on a flatland for gait assessment. J Biomech. 2018 Apr 11;71:281-285. doi: 10.1016/j.jbiomech.2018.01.035. Epub 2018 Feb 8. — View Citation

Thewlis D, Waters A, Solomon LB, Perilli E. Investigating in vivo knee volumetric bone mineral density and walking gait mechanics in healthy people. Bone. 2021 Feb;143:115662. doi: 10.1016/j.bone.2020.115662. Epub 2020 Sep 25. — View Citation

Tsakanikas VD, Gatsios D, Dimopoulos D, Pardalis A, Pavlou M, Liston MB, Fotiadis DI. Evaluating the Performance of Balance Physiotherapy Exercises Using a Sensory Platform: The Basis for a Persuasive Balance Rehabilitation Virtual Coaching System. Front Digit Health. 2020 Nov 27;2:545885. doi: 10.3389/fdgth.2020.545885. eCollection 2020. — View Citation

Ueno R, Navacchia A, Schilaty ND, Myer GD, Hewett TE, Bates NA. Anterior Cruciate Ligament Loading Increases With Pivot-Shift Mechanism During Asymmetrical Drop Vertical Jump in Female Athletes. Orthop J Sports Med. 2021 Mar 9;9(3):2325967121989095. doi: 10.1177/2325967121989095. eCollection 2021 Mar. — View Citation

Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med. 2011 Feb;26(2):192-6. doi: 10.1007/s11606-010-1513-8. Epub 2010 Sep 21. — View Citation

Wochatz M, Tilgner N, Mueller S, Rabe S, Eichler S, John M, Voller H, Mayer F. Reliability and validity of the Kinect V2 for the assessment of lower extremity rehabilitation exercises. Gait Posture. 2019 May;70:330-335. doi: 10.1016/j.gaitpost.2019.03.020. Epub 2019 Mar 26. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Hip, Knee and Spine Measurements angles 1 hour
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