ScoliosisNCT04764136
Reliability and Validity of a New Device Measuring Spinal Rotation on the Transverse Plane
An observational study of Scoliosis, run by University of Athens at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Scoliometer (scolioscope)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 6 May 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Anyone with thoracic and/or lumbar scoliosis
Who may be able to join
- Exclusion Criteria: recent spinal surgery, cancer, spinal fixation
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Motus Liberi Physiotherapy Centre
Athens, Attica, 11471
GEORGIOS KREKOUKIAS, PT, PhD, 6934609400, gkrekos@gmail.com
Vasiliki Kalidoni, PT, +306937647333, vkalidoni19@gmail.com
About this study
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
Read the 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
- Conditions
- Scoliosis
- Being tested
- Scoliometer (scolioscope)
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
Reliability of device on repeated measures both intra and inter observer
Measured: 2021-2022
Validity
Validity of device will be measured
Measured: 2021-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start6 May 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Krekoukias, University of Athens
- Investigators
- Konstantinos Soultanis, MD, Study chair, Attikon University Hospital, Athens, GreeceGEORGIOS KREKOUKIAS, PT, PhD, Principal investigator, PT, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764136
- Sponsor's protocol ID
- 18221
- Status last verified
- Oct 2021
- First submitted
- 18 Feb 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of a New Device Measuring Spinal Rotation on the Transverse Plane
- ClinicalTrials.gov ID
- NCT04764136
- Acronym / sponsor ID
- 18221
- Conditions
- Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anyone with thoracic and/or lumbar scoliosis
Key inclusion criteria (2 listed)
- Exclusion Criteria: recent spinal surgery, cancer, spinal fixation
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scoliometer (scolioscope)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. | Device | – |
Primary outcome
Reliability
Time frame: 2021-2022
Reliability of device on repeated measures both intra and inter observer
Validity
Time frame: 2021-2022
Validity of device will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Soultanis, MD study chair
Attikon University Hospital, Athens, Greece
GEORGIOS KREKOUKIAS, PT, PhD principal investigator
PT, PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Krekoukias, PT, PhD (+306934609400, gkrekos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: 2021-2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.