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Validation of the DyCare® Lynx System for Motion Analysis of the Wrist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04773535
Recruitment Status : Completed
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

This project is set to compare the wrist joint movement measurements of the DyCare® Lynx System with optoelectronic motion analysis using a marker system and infrared cameras.

A total of 10 healthy test persons will be subjected to both the DyCare® Lynx and the Vicon® measurements during standard movements as well as during activities of daily living. The wrist joint angles measured with both systems will be compared.


Condition or disease Intervention/treatment
Healthy Volunteers Device: 3D Motion analysis

Detailed Description:

The accepted laboratory gold standards for human motion analysis are too over-elaborated for clinical use. The DyCare® Lynx system is user-friendly and has been proven reliable for motion evaluation of different joints, but not yet for the wrist.

Therefore, this project is set to compare the wrist joint movement measurements of the DyCare® Lynx System with optoelectronic motion analysis using a marker system and infrared cameras. DyCare® Lynx is based on two inertial sensors (DyTrack) capable of objectively measuring three dimensional joint movements in real time. Each inertial sensor includes an accelerometer, gyroscope and magnetometer and captures up to 1'000 samples per second. DyCare® Lynx is certified for measurements on the human musculoskeletal apparatus (EN ISO 13485:2003 Certificate No. 15185 - M), is CE marked and will only be applied to each participant for a few minutes during the measurements. The control measurements will be conducted using a Vicon® motion capture system in the Motion Analysis Laboratory of the Department of Plastic Surgery and Hand Surgery of the University Hospital of Zurich. The Vicon® system is equipped with 11 infrared cameras. The system is made for 'Life science application' and is approved as CE medical device. A total of 10 healthy test persons will be subjected to both the DyCare® Lynx and the Vicon® measurements during standard movements as well as during activities of daily living. The wrist joint angles measured with both systems will be compared, therefore limits of agreement, maximum difference and root mean squared difference will be calculated to quantify the deviation between methods. The standard error of measurements will be calculated to determine repeatability of the systems.

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of the DyCare® Lynx System for Motion Analysis of the Wrist During Standard Movements and Daily Activities
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : December 31, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
healthy Volunteers
Adult (>18y) healthy volunteers without previous injuries or pathologies of the hand and upper extremity
 Device: 3D Motion analysis
Motion analysis using DyCare® Lynx system with inertial based sensors as well as an optoelectronic motion analysis system based on infrared cameras (11x Vicon infrared high speed cameras)


Outcome Measures
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Primary Outcome Measures :
  1. Active wrist movement at standard movements [ Time Frame: October 2019 ]
    Ten healthy subjects will be recorded (3D motion analysis) while performing flexion-extension and radial-ulnar deviation movements of their right wrist using inertial sensors and skin markers


Secondary Outcome Measures :
  1. Active Wrist movement during activities of daily living. [ Time Frame: January 2020-August 2021 ]
    Ten healthy subjects will be recorded (3D motion analysis) while performing during ADLs: opening a jar, opening a lid pot, turning a key, dart-throwing.

  2. Comfort of the wearable Sensors [ Time Frame: October 2019 ]
    questionnaire looking into six dimensions of comfort as proposed by Knight and Baber (Knight, J.F.; Baber, C. A tool to assess the comfort of wearable computers. Human Factors 2005, 47, 77-91, doi:10.1518/0018720053653875.

  3. Time Consumption of measurements using DyCare® Lynx [ Time Frame: October 2019 ]
    Minutes necessary to attach the sensors to the patients and to record the movements.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
10 healthy volunteers
Criteria

Inclusion Criteria:

  • 10 test persons with healthy right-dominant hands
  • Test Persons older than 18 Years
  • Test persons willing and able to give written informed consent to participate in the study

Exclusion Criteria:

  • Inflammatory disease (e.g. rheumatoid arthritis)
  • German language barrier to understand instructions
  • Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
  • Legal incompetence
  • Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773535


Locations
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Switzerland
University Hospital Zurich, Clinic of Reconstructive Surgery
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Maurizio Calcagni, PD Dr. med University of Zurich
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04773535    
Other Study ID Numbers: BASEC 2018-00457
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No