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Musculoskeletal Diseases or ConditionsNCT05370534

Smartphone-Based Markerless Motion Capture for Orthopaedic Clinical Use

An observational study of Musculoskeletal Diseases or Conditions, run by University of Arkansas at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Diseases or Conditions
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Dec 2023to 18 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 18-65 years old
  • No known spinal pathology
  • No previous lower extremity surgery
  • No significant cardiac history

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

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.

Read the detailed 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.

Keywords
Motion Capture, MCA, Markers, Markerless, biomechanics
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05370534
Study groupRoleWhat they receive
Study PopulationThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hip, Knee and Spine Measurements

    angles

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2022
  2. Study start1 Dec 2023
  3. Primary completion18 Dec 2023
  4. Study completion18 Dec 2023

Why it stopped: Funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05370534
Sponsor's protocol ID
274321
Other IDs
GM125503
Status last verified
Feb 2023
First submitted
6 May 2022
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Principal Investigator will carefully monitor study procedures to protect the safety of research subjects and the potential for loss of confidentiality.

Publications

  • 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.

    PubMed 32987197

  • 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.

    PubMed 32693350

  • 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.

    PubMed 31929870

  • 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.

    PubMed 34235227

  • 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.

    PubMed 34339317

  • 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.

    PubMed 34480582

  • 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.

    PubMed 34713032

  • 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.

    PubMed 34640930

  • 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.

    PubMed 32807306

  • 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.

    PubMed 30947108

  • 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.

    PubMed 29681441

  • 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.

    PubMed 3450848

  • 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.

    PubMed 20857339

  • 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.

    PubMed 19013070

  • 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.

    PubMed 29475751

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal Diseases or Conditions, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hip, Knee and Spine Measurements (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05370534, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.

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