Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis

Study Purpose

This study will compare shoulder range of motion assessment using the Kinect motion tracking system vs.#46;goniometer in patients with adhesive capsulitis (frozen shoulder) undergoing ultrasound-guided capsular distention procedures (standard of care). The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. diagnosis of limited ROM due to adhesive capsulitis. 2. duration of symptoms of ≥ 3 months. 3. persistent functional limitation (defined as either limitations occupationally, in independent activities of daily living, or activities of daily living) 4. X-rays and MRI excluding alternative diagnosis. 5. age 18 years or older.

Exclusion Criteria:

1. prior shoulder surgery on the affected side. 2. complete rotator cuff tear (based on clinical history, examination, and imaging) or planned surgical intervention on the affected side. 3. ipsilateral subacromial injection within the last 3 months. 4. autoimmune or rheumatologic disease affecting the joints. 5. lack of scheduled same-day physical therapy appointment. 6. inability to complete follow-up appointments or surveys. 7. inability to provide informed consent. 8. symptomatic glenohumeral or acromioclavicular pathology. 9. referred pain from the neck or internal organs. 10. generalized myofascial pain syndrome

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04413162
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, Davis
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kevin Mullins, MD
Principal Investigator Affiliation	UC Davis Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adhesive Capsulitis, Adhesive Capsulitis of Shoulder, Frozen Shoulder, Shoulder Frozen, Shoulder Pain, Mobility Limitation
Study Website:	View Trial Website

Additional Details

The study will be a single-center, investigator-initiated protocol to assess the reliability of the Kinect Motion Analysis 2.0 Motion Tracking System for Range Of Motion (ROM) assessment in patients with Shoulder Adhesive Capsulitis undergoing ultrasound guided capsular distention procedures (standard of care for adhesive capsulitis). Secondarily, the study will describe the relationship between range of motion of the shoulder girdle in the four quadrants of normalized reachable workspace by the Kinect 2.0, PROMIS person-reported outcome scores for pain, pain interference and function (general mobility and upper extremity function), and VAS pain scores. Study participants are anticipated to remain in the study for 12 weeks: an initial visit followed by 6- and 12-week follow up visits. Given the nature of scheduling appointments in medical clinics, 12 weeks is an approximation; the actual duration may occasionally be 1-2 weeks longer if needed to successfully complete the follow-up visit. The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

Arms & Interventions

Arms

Other: measurement before and after capsular distention

Interventions

Other: - Kinect motion tracking system

Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC Davis Sports Medicine, Sacramento, California

Status

Recruiting

Address

UC Davis Sports Medicine

Sacramento, California, 95816

Site Contact

Brandon Hassid, MD

[email protected]

916-734-6805

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