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CompletedNCT04413162Updated Apr 3, 2025

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

An interventional study of Kinect motion tracking system in Adhesive Capsulitis, Adhesive Capsulitis of Shoulder and Frozen Shoulder, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by University of California, Davis · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • adhesive capsulitis
  • frozen shoulder
  • shoulder pain
  • range of motion
  • capsular distention
  • capsular distension
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Other
    measurement before and after capsular distention

    Other: Kinect motion tracking system

Interventions

  • OtherKinect motion tracking system

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

05

What researchers measure

Primary outcomes

  1. change in shoulder range of motion

    measured in degrees (high number of degrees = better range of motion)

    Time frame: 12 weeks

Secondary outcomes

  1. 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)

    Time frame: 12 weeks

  2. 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)

    Time frame: 12 weeks

  3. VAS score

    Visual analog scale is a validated, subjective measure for pain. Range of possible values: 0-10. (Higher score indicates more pain)

    Time frame: 12 weeks

06

Study locations

1 site
  • UC Davis Sports Medicine
    Sacramento, California 95816, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT04413162
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Jun 2, 2020
Start date
Jun 10, 2020
Primary completion
Feb 7, 2025
Completion
Feb 7, 2025
Last update
Apr 3, 2025

Study contacts

Kevin Mullins, MD
principal investigator · UC Davis Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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