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

Primary Purpose

Adhesive Capsulitis, Adhesive Capsulitis of Shoulder, Frozen Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinect motion tracking system
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adhesive Capsulitis focused on measuring adhesive capsulitis, frozen shoulder, shoulder pain, range of motion, capsular distention, capsular distension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UC Davis Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

measurement before and after capsular distention

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2020
Last Updated
August 15, 2022
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04413162
Brief Title
Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis
Official Title
Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
measurement before and after capsular distention
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Kinect motion tracking system
Intervention Description
Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.
Primary Outcome Measure Information:
Title
change in shoulder range of motion
Description
measured in degrees (high number of degrees = better range of motion)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PROMIS score - upper extremity
Description
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
Title
DASH score
Description
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
Title
VAS score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Hassid, MD
Phone
916-734-5292
Email
bvhassid@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Sheng, MD
Email
dana.sheng@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Mullins, MD
Organizational Affiliation
UC Davis Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Sports Medicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Hassid, MD
Phone
916-734-6805
Email
bvhassid@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Kevin Mullins, MD

12. IPD Sharing Statement

Links:
URL
https://studypages.com/s/using-kinect-motion-capture-to-measure-shoulder-motion-for-capsular-distension-in-adhesive-capsulitis-frozen-shoulder-654329/
Description
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Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis

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