Osteoarthritis, HipNCT04137835
Non-invasive Evaluation of Upper and Lower Body Function With Showmotion
A study testing Showmotion in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Spine
- What is being tested?
- Showmotion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age > 65, < 18
- Active infections
- Surgery at joint of interest
- BMI (Body Mass Index) >30 kg/m2
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Vikas Patel, MD, VIKAS.PATEL@CUANSCHUTZ.EDU
About this study
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.
Read the 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.
- Being tested
- Showmotion
- Keywords
- osteoarthritis
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Spine, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShowmotionDevice
Each healthy volunteers will wear sensors at the interested joint and do the measurement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Showmotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Jun 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikas Patel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137835
- Sponsor's protocol ID
- 19-2272
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2019
- Last updated
- 4 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Upper and Lower Body Function With Showmotion
- ClinicalTrials.gov ID
- NCT04137835
- Acronym / sponsor ID
- 19-2272
- Keywords
- osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Showmotion | Experimental | Device: ShowmotionPerforming 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Age > 65, < 18
- Active infections
- Surgery at joint of interest
- BMI (Body Mass Index) >30 kg/m2
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShowmotionEach healthy volunteers will wear sensors at the interested joint and do the measurement. | Device | Showmotion |
Primary outcome
range of motion
Time frame: 1 HOUR
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vikas Patel, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Showmotion in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CLAIRE COFER, BS (303-724-1588, CLAIRE.COFER@CUANSCHUTZ.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (time frame: 1 HOUR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.