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Completed

NCT Number: NCT04413162

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Sports Medicine

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Kinect motion tracking system

Other

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

Primary outcomes

  1. change in shoulder range of motion

    Time frame: 12 weeks

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2020
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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