Forces and Translation Distance During an Inferior Glide of the Shoulder

• Sponsor: Dr. Rob Sillevis, (Other)
• Overall Status: Completed
• CT.gov ID: NCT04775628
• Collaborator: Mitchell Todd (Other), J.P Speare (Other), Eric Shamus (Other), Arie van Duijn (Other)
• Enrollment: 64
• Location: 1
• Arm: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

This study evaluates the force and translation distance in the GH joint during a manual inferior glide of the humerus.

Condition or Disease	Intervention/Treatment	Phase
Asymptomatic Condition	Procedure: Inferior glide humerus in GH joint	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Within subject designWithin subject design
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Forces and Translation Distance During an Inferior Glide of the Shoulder in Healthy Subjects Measured With the Novel Pliance Glove and Ultrasound Imaging
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: inferior glide Inferior glide of the right humerus till no motion is visual on the imaging	Procedure: Inferior glide humerus in GH joint; Supine inferior glide GH joint

Outcome Measures

Primary Outcome Measures

1. Translation [5 minutes]

   Measured in mm using MSK Ultrasound

2. Force measure [5 minutes]

   Force measure during inferior glide using Novel Pliance Glove

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Gulf Coast University	Fort Myers	Florida	United States	33965

Sponsors and Collaborators

• Dr. Rob Sillevis,
• Mitchell Todd
• J.P Speare
• Eric Shamus
• Arie van Duijn

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Rob Sillevis,, Assistent Professor, Florida Gulf Coast University
• ClinicalTrials.gov Identifier: NCT04775628
• Other Study ID Numbers: 2018-015
• First Posted: Mar 1, 2021
• Last Update Posted: Apr 7, 2022
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Rob Sillevis,, Assistent Professor, Florida Gulf Coast University: Manipulation force; Glenohumeral joint; Musculoskeletal Ultrasound Imaging
• Additional relevant MeSH terms: Asymptomatic Diseases

Study Results

No Results Posted as of Apr 7, 2022