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

Shoulder Pain Clinical Trial

Official title:

Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413162
• Other study ID #: 1490166
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2022
• Source: University of California, Davis
• Contact: Brandon Hassid, MD
• Phone: 916-734-5292
• Email: bvhassid[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare shoulder range of motion assessment using the Kinect motion tracking system vs 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Adhesive Capsulitis of Shoulder
• Bursitis
• Frozen Shoulder
• Mobility Limitation
• Shoulder Frozen
• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis Sports Medicine	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in shoulder range of motion	measured in degrees (high number of degrees = better range of motion)	12 weeks
Secondary	PROMIS score - upper extremity	Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated, 46-item, self-reported system to assess physical function and symptoms in patients with disorders of the limb. Range of possible values: 46-230. (Higher score indicates higher function and outcomes)	12 weeks
Secondary	DASH score	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 38-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Range of possible values: 38-150. (Lower score indicates better function / less disability)	12 weeks
Secondary	VAS score	Visual analog scale is a validated, subjective measure for pain. Range of possible values: 0-10. (Higher score indicates more pain)	12 weeks

External Links

•   Learn more or sign up for the study here!