Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder
1 other identifier
interventional
105
1 country
1
Brief Summary
The purpose of this study is to measure the amount of movement between the bones of the shoulder joint when mobilization techniques are applied by a physical therapist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 5, 2015
CompletedFirst Posted
Study publicly available on registry
January 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2019
CompletedApril 22, 2019
April 1, 2019
7 years
January 5, 2015
April 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Movement of the humeral head
The movement of the humeral head in reference to the glenoid fossa is recorded using ultrasound imaging. The amount of movement (as measured in millimeters) between the image taken on rest and the image taken during the manual mobilization is calculated for each direction of manual mobilization. This primary outcome measure is obtained during the performance of the manual mobilization. Subjects are tested and this primary outcome measured during the intervention (manual mobilization) on Day one and, within one week, on Day two. Each subject participates in the study for approximately one week.
Immediate measurement of humeral head movement concurrent with application of manual mobilization
Secondary Outcomes (1)
Force of Mobilization
Immediate measurement of force used during the application of manual mobilization
Study Arms (1)
Manual Mobilization
EXPERIMENTALGrade I, II and III manual mobilizations in the inferior, posterior and distractive directions.
Interventions
Stabilization of the glenoid fossa with movement of the humerus using varying degrees of force as applied by a physical therapist. Subject is positioned with the shoulder in 55 degrees of abduction and 30 degrees of horizontal adduction. Manual force is applied by a physical therapist on the proximal humeral head moving the humeral head posterior, inferior or lateral (distraction). An ultrasound transducer placed over the anterior shoulder joint provides imaging of the humeral head and the glenoid fossa. This manual intervention is repeated three times in each direction on each arm.
Eligibility Criteria
You may qualify if:
- asymptomatic subjects with no history of neck, shoulder, or arm pain; full active pain free range of motion at the cervical spine and shoulders
You may not qualify if:
- neuromuscular or musculoskeletal disorders; connective tissue disorders such as rheumatoid arthritis; inflammatory conditions such as Crohns disease; Down's syndrome; Marfan's syndrome; medically diagnosed hypermobility; history of neck, shoulder or arm trauma, pain, or surgery including dislocation and rotator cuff tears; pregnancy; and metal implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Dexter Witt, DHS
University of Cincinnati
- PRINCIPAL INVESTIGATOR
Nancy Talbott, PhD
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 5, 2015
First Posted
January 14, 2015
Study Start
April 1, 2012
Primary Completion
March 26, 2019
Study Completion
March 26, 2019
Last Updated
April 22, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share