Validation of the DyCare® Lynx System for Motion Analysis of the Wrist
NCT ID: NCT04773535
Last Updated: 2021-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2018-03-01
2019-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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healthy Volunteers
Adult (\>18y) healthy volunteers without previous injuries or pathologies of the hand and upper extremity
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Test Persons older than 18 Years
* Test persons willing and able to give written informed consent to participate in the study
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Maurizio Calcagni, PD Dr. med
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Zurich, Clinic of Reconstructive Surgery
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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BASEC 2018-00457
Identifier Type: -
Identifier Source: org_study_id