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

NCT04773535 | Completed

• 1 other identifier: BASEC 2018-00457
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Active Wrist movement during activities of daily living.

  January 2020-August 2021

• Comfort of the wearable Sensors

  October 2019

• Time Consumption of measurements using DyCare® Lynx

  October 2019

Study Arms (1)

healthy Volunteers

Adult (\>18y) healthy volunteers without previous injuries or pathologies of the hand and upper extremity

Device: 3D Motion analysis

Interventions

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)

healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Clinic of Reconstructive Surgery

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

• Maurizio Calcagni, PD Dr. med

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: February 26, 2021
• Study Start: March 1, 2018
• Primary Completion: March 28, 2019
• Study Completion: December 31, 2019
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

CH (1)