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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773535
• Other study ID #: BASEC 2018-00457
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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)

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Clinic of Reconstructive Surgery	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active wrist movement at standard movements	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	October 2019
Secondary	Active Wrist movement during activities of daily living.	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.	January 2020-August 2021
Secondary	Comfort of the wearable Sensors	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.	October 2019
Secondary	Time Consumption of measurements using DyCare® Lynx	Minutes necessary to attach the sensors to the patients and to record the movements.	October 2019