Biomechanical Analysis of Scapula and Humerus With Differ... | NCT04749472

Studies
Biomechanical Analysis of Scapula and Humerus With Different Shoulder Slings

NCT04749472

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Feb 11, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Shoulder Injuries
Surgery

Interventions

Sling

Countries

Turkey (Türkiye)

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

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2021Estimated

Primary Completion Date

Sep 12, 2022Estimated

Completion Date

Dec 20, 2022Estimated

First Submitted Date

Feb 7, 2021

First Submission Date that Met QC Criteria

Feb 7, 2021

First Posted Date

Feb 11, 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

Feb 7, 2021

Last Update Posted Date

Feb 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Participants will be measured with motion monitor system while using 6 different slings. Measurement order will be randomized, and 5 minutes resting period will be given prior measurement. Scapula, humerus and thorax positions will be recorded in resting position and then with slings.

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Participants received intervention.	Other: Sling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sling	Other	Participants wore six different shoulder slings in a randomized order.	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Motion Monitor	Motion monitor device was used to analyze 3D positions of the arm, shoulder, scapula and thorax.	During rest position without and with different slings for 5 seconds.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Having a shoulder surgery
Having scapular dyskinesis,
Having shoulder pain,
Having any disease that could affect posture and/or shoulder (such as scoliosis)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elif Turgut, Assoc Prof.	Contact	+905442645600		elif.turgut.pt@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University		Ankara		06100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D000070599	Shoulder Injuries

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053825	Suburethral Slings

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided