NCT05370534

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

December 26, 2023

Status Verified

February 1, 2023

Enrollment Period

17 days

First QC Date

May 6, 2022

Last Update Submit

December 19, 2023

Conditions

Keywords

Motion CaptureMCAMarkersMarkerlessbiomechanics

Outcome Measures

Primary Outcomes (1)

  • Hip, Knee and Spine Measurements

    angles

    1 hour

Study Arms (1)

Study Population

The investigators anticipate validating two specific actions: a box jump and walking gait. Both will be captured in two planes, coronal and sagittal. Healthy patients without musculoskeletal complaints will be voluntarily enrolled to undergo motion capture with both methods, completed during the same visit to the UAMS Human Biomechanics Laboratory. Each patient will perform a box jump and walking gait using each of the two modalities. We anticipate 4 hrs will be required for each patient: 1 hr for setup before the patient arrives, 1 hr for testing, and 2 hrs for data cleaning and initial processing. This work will be performed at the UAMS Human Biomechanics Laboratory (off campus on Aldersgate Road), which is equipped for this type of analysis.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be males and females between the ages of 18 years old to 65 years old that are healthy and without any active injuries limiting full participation, in particular no known spinal pathology, history of lower extremity surgery or significant cardiac history. There are no restrictions based on gender, race, or ethnicity.

You may qualify if:

  • years old
  • No known spinal pathology
  • No previous lower extremity surgery
  • No significant cardiac history

You may not qualify if:

  • \<18 or \>65 years old
  • Known spinal pathology
  • Previous lower extremity surgery
  • Significant cardiac history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (15)

  • 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.

    PMID: 32987197BACKGROUND
  • 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.

    PMID: 32693350BACKGROUND
  • 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.

    PMID: 31929870BACKGROUND
  • 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.

    PMID: 34235227BACKGROUND
  • 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.

    PMID: 34339317BACKGROUND
  • 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.

    PMID: 34480582BACKGROUND
  • 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.

    PMID: 34713032BACKGROUND
  • 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.

    PMID: 34640930BACKGROUND
  • 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.

    PMID: 32807306BACKGROUND
  • 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.

    PMID: 30947108BACKGROUND
  • 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.

    PMID: 29681441BACKGROUND
  • 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.

    PMID: 3450848BACKGROUND
  • 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.

    PMID: 20857339BACKGROUND
  • 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.

    PMID: 19013070BACKGROUND
  • 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.

    PMID: 29475751BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • David B Bumpass, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

December 1, 2023

Primary Completion

December 18, 2023

Study Completion

December 18, 2023

Last Updated

December 26, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

The Principal Investigator will carefully monitor study procedures to protect the safety of research subjects and the potential for loss of confidentiality.

Locations