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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Clinic of Reconstructive Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

10 healthy volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time Consumption of measurements using DyCare® Lynx	Minutes necessary to attach the sensors to the patients and to record the movements.	October 2019

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Maurizio Calcagni, PD Dr. med, University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): March 28, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (ACTUAL): February 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BASEC 2018-00457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No