- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04775628
Forces and Translation Distance During an Inferior Glide of the Shoulder
March 29, 2022 updated by: Dr. Rob Sillevis,
Forces and Translation Distance During an Inferior Glide of the Shoulder in Healthy Subjects Measured With the Novel Pliance Glove and Ultrasound Imaging
This study evaluates the force and translation distance in the GH joint during a manual inferior glide of the humerus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There has been limited research on how the variance of force affects MT outcomes and what the best practices of MT should be.
No specific force threshold necessary to achieve a predetermined translational distance within the joint has been quantified within the literature.
The purpose of this study was to quantify the amount of force necessary to perform an inferior glide to the glenohumeral joint and reach to end-range.
A secondary aim was to determine the impact of co-variables, such as gender, height, weight, and age, on the amount of force required to translate the humeral head within the glenohumeral joint.
Musculoskeletal Ultrasound imaging using the GE LogiQe was used to measure the translation of the humeral head.
The manipulation force was measured using the Novel Pliance Glove device and software.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Fort Myers, Florida, United States, 33965
- Florida Gulf Coast University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
- Able to read the English language fluently
Exclusion Criteria:
- a history of injury of the right shoulder
- right shoulder surgery
- presence of shoulder pain
- comorbidities affecting natural ROM within the dominant shoulder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: inferior glide
Inferior glide of the right humerus till no motion is visual on the imaging
|
Supine inferior glide GH joint
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Translation
Time Frame: 5 minutes
|
Measured in mm using MSK Ultrasound
|
5 minutes
|
Force measure
Time Frame: 5 minutes
|
Force measure during inferior glide using Novel Pliance Glove
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2018
Primary Completion (ACTUAL)
November 1, 2018
Study Completion (ACTUAL)
May 1, 2019
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (ACTUAL)
March 1, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 7, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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