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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04137835
Other study ID # 19-2272
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2023

Study information

Verified date March 2023
Source University of Colorado, Denver
Contact CLAIRE COFER, BS
Phone 303-724-1588
Email CLAIRE.COFER@CUANSCHUTZ.EDU
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary range of motion measure, track, follow, compare the range of motion of anatomical articulations (such as shoulder and elbow for upper limb and hip and knee for lower limb) during movement, taking into account all clinical constraints related to easiness, quickness and portability. 1 HOUR
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