Forces and Translation Distance During an Inferior Glide... | NCT04775628

Studies
Forces and Translation Distance During an Inferior Glide of the Shoulder

NCT04775628

Sponsor

Dr. Rob Sillevis,

Status

Completed

Last Update Posted

Apr 7, 2022Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Asymptomatic Condition

Interventions

Inferior glide humerus in GH joint

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Nov 1, 2018Actual

Completion Date

May 1, 2019Actual

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Apr 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Rob Sillevis,, Assistent Professor, Florida Gulf Coast UniversitySponsor-Investigator

Lead Sponsor

Dr. Rob Sillevis,OTHER

Collaborators

Name	Class
Mitchell Todd	UNKNOWN
J.P Speare	UNKNOWN
Eric Shamus	UNKNOWN
Arie van Duijn

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inferior glide	Experimental	Inferior glide of the right humerus till no motion is visual on the imaging	Procedure: Inferior glide humerus in GH joint

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inferior glide humerus in GH joint	Procedure	Supine inferior glide GH joint	inferior glide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Translation	Measured in mm using MSK Ultrasound	5 minutes
Force measure	Force measure during inferior glide using Novel Pliance Glove	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Gulf Coast University		Fort Myers	Florida	33965	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058070	Asymptomatic Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided