NCT04764136

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

February 18, 2021

Last Update Submit

October 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reliability

    Reliability of device on repeated measures both intra and inter observer

    2021-2022

  • Validity

    Validity of device will be measured

    2021-2022

Interventions

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.

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Anyone with thoracic and/or lumbar scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motus Liberi Physiotherapy Centre

Athens, Attica, 11471, Greece

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Konstantinos Soultanis, MD

    Attikon University Hospital, Athens, Greece

    STUDY CHAIR
  • GEORGIOS KREKOUKIAS, PT, PhD

    PT, PhD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Krekoukias, PT, PhD

CONTACT

Vasiliki Kalidoni

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doctoral researcher

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

May 6, 2021

Primary Completion

October 31, 2021

Study Completion

November 30, 2021

Last Updated

November 8, 2021

Record last verified: 2021-10

Locations