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Completed

NCT Number: NCT04773535

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Clinic of Reconstructive Surgery

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Motion analysis

Device

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Validation of the DyCare® Lynx System for Motion Analysis of the Wrist During Standard Movements and Daily Activities

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2021
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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