search
Back to results

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

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Spine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Showmotion
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Hip focused on measuring osteoarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Showmotion

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2019
Last Updated
March 3, 2023
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT04137835
Brief Title
Non-invasive Evaluation of Upper and Lower Body Function With Showmotion
Official Title
Non-invasive Evaluation of Upper and Lower Body Function With Showmotion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Spine
Keywords
osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Showmotion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Showmotion
Intervention Description
Each healthy volunteers will wear sensors at the interested joint and do the measurement.
Primary Outcome Measure Information:
Title
range of motion
Description
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.
Time Frame
1 HOUR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CLAIRE COFER, BS
Phone
303-724-1588
Email
CLAIRE.COFER@CUANSCHUTZ.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikas Patel, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas Patel, MD
Email
VIKAS.PATEL@CUANSCHUTZ.EDU

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs