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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413162
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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.


Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Adhesive Capsulitis of Shoulder Frozen Shoulder Shoulder Frozen Shoulder Pain Mobility Limitation Other: Kinect motion tracking system Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
measurement before and after capsular distention Other: Kinect motion tracking system
Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.




Primary Outcome Measures :
  1. change in shoulder range of motion [ Time Frame: 12 weeks ]
    measured in degrees (high number of degrees = better range of motion)


Secondary Outcome Measures :
  1. PROMIS score - upper extremity [ Time Frame: 12 weeks ]
    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)

  2. DASH score [ Time Frame: 12 weeks ]
    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)

  3. VAS score [ Time Frame: 12 weeks ]
    Visual analog scale is a validated, subjective measure for pain. Range of possible values: 0-10. (Higher score indicates more pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413162


Contacts
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Contact: Dana Sheng, MD 916-734-5292 DLSHENG@UCDAVIS.EDU

Locations
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United States, California
UC Davis Sports Medicine Recruiting
Sacramento, California, United States, 95816
Contact: Dana Sheng    916-734-6805    DLSHENG@UCDAVIS.EDU   
Principal Investigator: Brian Davis, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Brian Davis, MD UC Davis Health
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04413162    
Other Study ID Numbers: 1490166
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
adhesive capsulitis
frozen shoulder
shoulder pain
range of motion
capsular distention
capsular distension
Additional relevant MeSH terms:
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Shoulder Pain
Bursitis
Mobility Limitation
Dilatation, Pathologic
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical