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

October 29, 2021 updated by: Georgios Krekoukias, University of Athens
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georgios Krekoukias, PT, PhD
  • Phone Number: +306934609400
  • Email: gkrekos@gmail.com

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11471
        • Recruiting
        • Motus Liberi Physiotherapy Centre
        • Contact:
        • Contact:

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

6 years to 86 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Anyone with thoracic and/or lumbar scoliosis

Description

Inclusion Criteria: lumbar and thoracic scoliosis -

Exclusion Criteria: recent spinal surgery, cancer, spinal fixation

-

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

  • Study Chair: Konstantinos Soultanis, MD, Attikon University Hospital, Athens, Greece
  • Principal Investigator: GEORGIOS KREKOUKIAS, PT, PhD, PT, PhD

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)

May 6, 2021

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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