ScoliosisNCT05764499
Physiotherapy Scoliosis Specific Exercise Improves Truncal Shift in Idiopathic Scoliosis
An observational study of Scoliosis and Apical Deviation, run by Scoliosis SOS Ltd. at 1 site in United Kingdom.
Trial summary
Introduction: Truncal shift caused by scoliosis can be measured with a Formetric Scanner using the Maximal Thoracic Apical Deviation (MTAD) measurement. It is a well-documented complaint with regards to body-image in patients with idiopathic scoliosis (IS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scoliosis, Apical Deviation, Adolescent Idiopathic Scoliosis
- What is being tested?
- Physiotherapy Scoliosis Specific Exercise (PSSE)
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants were all consecutive patients at the Scoliosis SOS Clinic in London, a private healthcare clinic specializing in non-invasive treatment for Scoliosis. All patients were routinely completing their treatment.
Who may be able to join
- Patients who completed the group treatment program in its entirety. Patients who have measurements obtained from all necessary time points. Patient who have Scoliosis and who have a primary thoracic curvature.
Who cannot join
- Patient who did not complete treatment or all measurements obtained. Patients who underwent surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy Scoliosis Specific Exercise Improves Truncal Shift in Idiopathic Scoliosis: a 24 Month Follow up
Introduction: Truncal shift caused by scoliosis can be measured with a Formetric Scanner using the Maximal Thoracic Apical Deviation (MTAD) measurement. It is a well-documented complaint with regards to body-image in patients with idiopathic scoliosis (IS). Furthermore, thoracic apical deviation is an important measure in pre-operative assessment and post-operative outcomes.
Objective: The aim of this retrospective cohort study was to determine the long-term effects of an intensive course of Physiotherapy Scoliosis Specific Exercise (PSSE) on MTAD in patients with IS.
Methods: Consecutive IS patients with a single right-sided thoracic curvature who completed an intensive 4-week course of PSSE were recruited. Data was collected between April 2019 and December 2021. All patients were routinely scanned using a Formetric Scanner pre-, immediately post-, 12- and 24-months post-treatment. MTAD, measured in millimetres, was documented. Adults (>17 years old) (group 1) and children (group 2) were analysed separately.
- Conditions
- Scoliosis, Apical Deviation, Adolescent Idiopathic Scoliosis
- Being tested
- Physiotherapy Scoliosis Specific Exercise (PSSE)
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy Scoliosis Specific Exercise (PSSE)Other
Patients completed 120 hours of group based PSSE over a four week time frame. Monday - Friday, 10.00-17.00.
| Study group | Role | What they receive |
|---|---|---|
| Children | Patients under the age of 18 Receives: Other: Physiotherapy Scoliosis Specific Exercise (PSSE) | |
| Adults | Patients 18 years old and above Receives: Other: Physiotherapy Scoliosis Specific Exercise (PSSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Thoracic Apical Deviation
Maximal Apical Deviation measurement in mm, obtained from the DIERS 4D Formetric Scanner
Measured: Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment
Secondary outcomes (1)
Body Image Score
Average Body Image Score. Average score from 5 categories, scored from 1-10.
Measured: Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Apr 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scoliosis SOS Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764499
- Sponsor's protocol ID
- ScoliosisSOS1
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No patient information or databases will be shared outside of the clinic
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Scoliosis Specific Exercise Improves Truncal Shift in Idiopathic Scoliosis: a 24 Month Follow up
- ClinicalTrials.gov ID
- NCT05764499
- Acronym / sponsor ID
- ScoliosisSOS1
- Conditions
- Scoliosis, Apical Deviation, Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Scoliosis SOS Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Mar 2023 (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.
Introduction: Truncal shift caused by scoliosis can be measured with a Formetric Scanner using the Maximal Thoracic Apical Deviation (MTAD) measurement. It is a well-documented complaint with regards to body-image in patients with idiopathic scoliosis (IS). Furthermore, thoracic apical deviation is an important measure in pre-operative assessment and post-operative outcomes.
Objective: The aim of this retrospective cohort study was to determine the long-term effects of an intensive course of Physiotherapy Scoliosis Specific Exercise (PSSE) on MTAD in patients with IS.
Methods: Consecutive IS patients with a single right-sided thoracic curvature who completed an intensive 4-week course of PSSE were recruited. Data was collected between April 2019 and December 2021. All patients were routinely scanned using a Formetric Scanner pre-, immediately post-, 12- and 24-months post-treatment. MTAD, measured in millimetres, was documented. Adults (>17 years old) (group 1) and children (group 2) were analysed separately.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Other: Physiotherapy Scoliosis Specific Exercise (PSSE)Patients under the age of 18 |
| Adults | – | Other: Physiotherapy Scoliosis Specific Exercise (PSSE)Patients 18 years old and above |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were all consecutive patients at the Scoliosis SOS Clinic in London, a private healthcare clinic specializing in non-invasive treatment for Scoliosis. All patients were routinely completing their treatment.
Key inclusion criteria (1 listed)
- Patients who completed the group treatment program in its entirety. Patients who have measurements obtained from all necessary time points. Patient who have Scoliosis and who have a primary thoracic curvature.
Key exclusion criteria (1 listed)
- Patient who did not complete treatment or all measurements obtained. Patients who underwent surgery.
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 |
|---|---|---|
| Physiotherapy Scoliosis Specific Exercise (PSSE)Patients completed 120 hours of group based PSSE over a four week time frame. Monday - Friday, 10.00-17.00. | Other | Adults, Children |
Primary outcome
Maximal Thoracic Apical Deviation
Time frame: Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment
Maximal Apical Deviation measurement in mm, obtained from the DIERS 4D Formetric Scanner
1 secondary outcome
Body Image Score
Time frame: Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No. No patient information or databases will be shared outside of the clinic
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Apical Deviation, run by Scoliosis SOS Ltd. at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Mar 2023. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Thoracic Apical Deviation (time frame: Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment). 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 10 Mar 2023.