Reliability and Validity of a New Device Measuring Spinal... | NCT04764136

Studies
Reliability and Validity of a New Device Measuring Spinal Rotation on the Transverse Plane

NCT04764136

Sponsor

University of Athens

Status

Unknown status

Last Update Posted

Nov 8, 2021Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Scoliosis

Interventions

Scoliometer (scolioscope)

Countries

Greece

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 6, 2021Actual

Primary Completion Date

Oct 31, 2021Estimated

Completion Date

Nov 30, 2021Estimated

First Submitted Date

Feb 18, 2021

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 21, 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

Oct 29, 2021

Last Update Posted Date

Nov 8, 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

The purpose of this research is to investigate the reliability and validity of a new device similar to a scoliometer. The intended name of the device will be Scolioscope

Detailed Description

Οne cohort of participants will be used and the reliability of the equipment will be used to test/retest the repeatability of the measurements

The validity will be measured against a gold standard for measuring angles

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Scoliometer (scolioscope)	Device	Individuals with scoliosis will participate in this study. The device will be used to determine spinal rotation on the transverse plane. Repeated measures will be taken.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability	Reliability of device on repeated measures both intra and inter observer	2021-2022
Validity	Validity of device will be measured	2021-2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: lumbar and thoracic scoliosis -

Exclusion Criteria: recent spinal surgery, cancer, spinal fixation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Anyone with thoracic and/or lumbar scoliosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georgios Krekoukias, PT, PhD	Contact	+306934609400		gkrekos@gmail.com
Vasiliki Kalidoni	Contact	+306937647333		vkalidoni19@gmail.om

Overall Officials

Name	Affiliation	Role
Konstantinos Soultanis, MD	Attikon University Hospital, Athens, Greece	Study Chair
GEORGIOS KREKOUKIAS, PT, PhD	PT, PhD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Motus Liberi Physiotherapy Centre	Recruiting	Athens	Attica	11471	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	May 23, 2022
Reset	Feb 27, 2023

Submission Tracking

Estimated Results First Submitted Date

May 23, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 23, 2022			Feb 27, 2023

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided