Motion Tracking for Frozen Shoulder

Overseen By Dana Sheng, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Prior shoulder surgery, Rotator cuff tear, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for measuring shoulder movement using a Kinect motion tracking system for individuals with frozen shoulder. The goal is to determine if this system provides quick and reliable results compared to the traditional goniometer, a tool for measuring joint angles. The trial targets those with limited shoulder movement due to frozen shoulder for at least three months, who experience difficulties in daily activities. Participants will undergo assessments before and after a standard treatment called capsular distention, which improves shoulder flexibility. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future shoulder movement assessments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Kinect motion tracking system is safe for assessing shoulder range of motion?

Research has shown that the Kinect motion tracking system is safe for people with frozen shoulder. In earlier studies, patients with frozen shoulder (also called adhesive capsulitis) experienced no negative side effects when using this system, indicating no safety concerns. The Kinect system has been tested for its ability to track shoulder movements and has consistently performed well. Based on the available evidence, it appears to be a safe and well-tolerated option for assessing shoulder movement in people with frozen shoulder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Kinect motion tracking system for frozen shoulder because it offers a new way to measure and track shoulder movement. Unlike traditional treatments that focus on physical therapy and injections, this system provides precise, real-time data on shoulder mobility. By accurately capturing movement before and after interventions like capsular distention, it helps tailor treatments more effectively to individual patients. This approach could lead to more personalized and efficient recovery plans, potentially speeding up recovery times for those with frozen shoulder.

What evidence suggests that the Kinect motion tracking system is effective for assessing frozen shoulder?

Research has shown that the Kinect motion tracking system, used by participants in this trial, can accurately measure shoulder movement. Studies have found it fairly reliable compared to traditional tools like goniometers, which measure joint angles. For individuals with adhesive capsulitis, or frozen shoulder, the Kinect system has been used without reported side effects. This suggests it is safe and may effectively assess shoulder movement in these patients. Additionally, the system might deliver faster and more efficient results than older methods. ^{4 6 7 8 9}

Who Is on the Research Team?

Kevin Mullins, MD

Principal Investigator

UC Davis Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a diagnosis of adhesive capsulitis (frozen shoulder) who have had symptoms for at least 3 months and experience significant limitations in daily activities. Participants must not have complete rotator cuff tears, recent injections, autoimmune diseases affecting joints, or prior surgery on the affected shoulder.

Inclusion Criteria

My symptoms have lasted for at least 3 months.

X-rays and MRI excluding alternative diagnosis

I have ongoing difficulties with work or daily activities.

Exclusion Criteria

Lack of scheduled same-day physical therapy appointment

Inability to complete follow-up appointments or surveys

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial visit for baseline measurement of shoulder range of motion using Kinect and goniometer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in shoulder range of motion and pain scores

12 weeks

2 visits (in-person) at 6 and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kinect motion tracking system

Trial Overview The study tests if the Kinect Motion Analysis system can measure shoulder movement more efficiently than traditional methods in patients with frozen shoulder undergoing standard capsular distention procedures to improve mobility.

How Is the Trial Designed?

Group I: measurement before and after capsular distention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04413162/using-kinect-motion-capture-to-measure-shoulder-motion-in-patients-undergoing-capsular-distension-for-adhesive-capsulitis

Using Kinect Motion Capture to Measure Shoulder ... This study will compare shoulder range of motion assessment using the Kinect motion tracking system vs goniometer in patients with adhesive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8705315/

The Reliability of the Microsoft Kinect and Ambulatory ... The Kinect and ambulatory sensor-based human motion tracking devices demonstrate moderate–good levels of intra- and inter-rater reliability to measure shoulder ...

3. researchgate.net researchgate.net/figure/Diagnostic-performance-of-the-Kinect-for-adhesive-capsulitis-with-different-cutoff-values_fig8_279304803

Diagnostic performance of the Kinect for adhesive ... Patients with adhesive capsulitis exhibited greater variability than healthy individuals. No adverse events were reported, supporting the safety of the system.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1877065725000211

Effects of augmented reality-based telerehabilitation in ... AR and Kinect sensor-based telerehabilitation for participants with ACS improved shoulder pain, functional outcomes, and quality of life, but did not show ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04316130

Real-time Interactive Digital Healthcare System in Frozen ... This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11991502/

Reliability and Validity of the Single-Camera Markerless ... Patients with adhesive capsulitis exhibited greater variability than healthy individuals. No adverse events were reported, supporting the safety ...

7. mdpi.com mdpi.com/1424-8220/21/24/8186

The Reliability of the Microsoft Kinect and Ambulatory ... The Kinect and ambulatory sensor-based human motion tracking devices demonstrate moderate–good levels of intra- and inter-rater reliability to measure shoulder ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9028631/

Comparative accuracy of a shoulder range motion ... The AIRDS system has the potential to be a safe, accurate, low-cost, and home-based sensor for measuring the movements of people with frozen ...

9. journals.lww.com journals.lww.com/md-journal/fulltext/2023/06020/validity_and_reliability_of_the_single_camera.8.aspx

Validity and reliability of the single camera marker less... This study aims to describe methods to evaluate the reliability and validity of a single camera marker less motion capture system that uses an RGB-depth sensor ...