Non-invasive Evaluation of Upper and Lower Body Function With Showmotion

NCT ID: NCT04137835

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-12-01

Brief Summary

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It is very important to understand joint and body kinematics and muscles activity in clinical settings, which is relevant to identify issues related to the spine, the upper and lower limbs due to injury.

In this study, the investigators will use an innovative platform, Showmotion to establish baseline of shoulder, hip, knee and spine kinematics and muscles activity from 60 healthy volunteers.

Detailed Description

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Upper and lower body functional evaluation is challenging and relevant to identify the issues related to injury. Current technique still stays at visual observation.

Showmotion™ (NCS Lab, Carpi, Italy) is an innovative platform that provides a comprehensive analysis to monitor motion patterns of the whole body using WISE sensors, proprietary wireless inertial and magnetic units (MIMU) developed by NCS Lab (Italy).

Using the data acquired from MIMU and validated protocols for upper and lower limbs, Showmotion is able to measure, objectify and store three dimensional kinematic variables highlighting underlying information and allowing an in-depth analysis of the movement in real time.

Compared to the classic motion analysis performed with cameras in special research laboratories, the Showmotion™ technology allows the user to analyze the movements of the subjects in any place, quickly, and without the need to a long process of data analysis.

Conditions

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Osteoarthritis, Hip Osteoarthritis, Knee Osteoarthritis, Spine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Showmotion

Performing an analysis requires the positioning of sensors on the patient's skin in predetermined positions, according to the related protocols. Each sensor positioned on patient's skin provides both raw data (accelerometer, magnetometer, gyroscope) and the orientation matrix, representing the orientation of the local System of Reference (SoR) with respect to a fixed SoR. A proprietary sensor-fusion algorithm allows provides an accurate estimate of the orientation, as assessed by stereo-photogrammetric system-based testing.

Data from each sensor are sampled at 50 Hz and transferred wirelessly to a laptop with a proprietary software that processes the data according to the biomechanical model chosen for the analysis.

Group Type EXPERIMENTAL

Showmotion

Intervention Type DEVICE

Each healthy volunteers will wear sensors at the interested joint and do the measurement.

Interventions

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Showmotion

Each healthy volunteers will wear sensors at the interested joint and do the measurement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy people (without musculoskeletal pathologies of the joint of interest)
* Age \> 18, \<65
* Volunteers given written informed consent
* Ability to understand and execute instructions at all stages of the procedure

Exclusion Criteria

* Age \> 65, \< 18
* Active infections
* Surgery at joint of interest
* BMI (Body Mass Index) \>30 kg/m2
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikas Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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CLAIRE COFER, BS

Role: CONTACT

303-724-1588

Facility Contacts

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Vikas Patel, MD

Role: primary

Other Identifiers

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19-2272

Identifier Type: -

Identifier Source: org_study_id

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