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

NCT04137835 | Recruiting FDA Device

• 1 other identifier: 19-2272
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Osteoarthritis, Spine

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Showmotion

EXPERIMENTAL

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.

Device: Showmotion

Interventions

Showmotion DEVICE

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

Showmotion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Osteoarthritis, Spine; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases

Study Officials

• Vikas Patel, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CLAIRE COFER, BS

CONTACT

303-724-1588; CLAIRE.COFER@CUANSCHUTZ.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: June 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)