Validation of the DyCare® Lynx System for Motion Analysis... | NCT04773535

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

NCT04773535

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Feb 26, 2021Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Healthy Volunteers

Interventions

3D Motion analysis

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Mar 28, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Nov 19, 2020

First Submission Date that Met QC Criteria

Feb 23, 2021

First Posted Date

Feb 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2021

Last Update Posted Date

Feb 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy Volunteers		Adult (>18y) healthy volunteers without previous injuries or pathologies of the hand and upper extremity	Device: 3D Motion analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

10 healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maurizio Calcagni, PD Dr. med	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Clinic of Reconstructive Surgery		Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided