Adolescent Idiopathic ScoliosisCTM biomecNCT05749562
Effect of a Brace on the Adolescent Idiopathic Scoliosis Breathing
An observational study of Adolescent Idiopathic Scoliosis, run by CHU de Reims at 1 site in France.
Trial summary
This study intends to investigate the effect of bracing on respiratory function in the treatment of adolescent idiopathic scoliosis (AIS). In particular, it will look at the effect of the brace on respiratory function and 3D volume of the thoracic cage. Read more about this study
- Who is it for?
- Ages 12 to 16 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Cheneau-Toulouse-Munster brace
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2023to 19 Mar 2024
- 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 12 to 16 years
- Women only
- No healthy volunteers
- Child
Study population: The study will be conducted with patients treated for scoliosis in the Department of Pediatric Surgery, at the American Memorial Hospital, CHU Reims.
Who may be able to join
- Adolescent girls aged 12 to 16
- With a right thoracic or thoraco-lumbar curvature (right and left)
- With a Cobb angle between 20 and 40°.
- Treated with a Cheneau-Toulouse-Munster brace for more than 1 month
- With a duration of brace wearing of more than 12/24h
- Affiliated to a social security system
Who cannot join
- Male gender
- Having a secondary scoliosis (neuromuscular, syndromic, post-traumatic, congenital pathology)
- Having a respiratory pathology prior to the diagnosis of scoliosis
- Have a history of spinal surgery
- Having already benefited from a brace treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of a Cheneau-Toulouse-Munster Brace in the Treatment of Adolescent Idiopathic Scoliosis on Respiratory Function
This study intends to investigate the effect of bracing on respiratory function in the treatment of adolescent idiopathic scoliosis (AIS). In particular, it will look at the effect of the brace on respiratory function and 3D volume of the thoracic cage. An additional evaluation of the pressure forces of the brace, using a connected t-shirt, will be carried out. The investigators hypothesise that the brace will decrease the respiratory parameters and 3D volume of the thoracic cage, especially during deep breathing.
Read the detailed description
Scoliosis is a 3D deformity of the spine with curvatures occurring in the three planes of space.
The brace is widely used for adolescent idiopathic scoliosis. The Cheneau-Toulouse-Munster (CTM) brace is a rigid brace, classically indicated for thoracic and lumbar curves. However, scoliosis induces structural deformation of the rib cage. This can lead to changes in thoracic volume associated with a respiratory disorder, mainly restrictive. But the effect of bracing on pulmonary function currently remains unclear.
Few studies in the literature have looked at the impact of the brace on lung function. In those studies, the findings were based on Pulmonary Function Test (PFT) results only. In the CTM biomec study, the investigators propose to evaluate lung function by PFT associated with biplanar radiography using EOS® system, which allows 3D modelling of the rib cage. An additional evaluation of the pressure forces of the CTM brace, using a connected t-shirt, will be carried out to better understand the biomechanics of the brace. It will allow us to observe the stress surfaces on the thorax during the respiratory cycle and to compare them with the adaptation kinematics of the thoracic cage.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Cheneau-Toulouse-Munster brace
- Keywords
- Adolescent, Female, Biomechanical Phenomena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheneau-Toulouse-Munster braceDevice
Full length, orthogonal anteroposterior and lateral X-rays will be taken with the Cheneau-Toulouse-Munster brace.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Idiopathic Scoliosis with right thoracic or thoraco-lumbar curvature | Patients will be treated with a Cheneau-Toulouse-Munster (CTM) brace, with a wearing time of more than 12 hours/24h, for more than 1 month. Receives: Device: Cheneau-Toulouse-Munster brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Lung Capacity (TLC)
change with and without the brace
Measured: 1 day
Secondary outcomes (1)
Forced expiratory volume in one second
change with and without the brace
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start17 Feb 2023
- Primary completion24 Aug 2023
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749562
- Sponsor's protocol ID
- PO23019*
- Acronym
- CTM biomec
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2023
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of a Cheneau-Toulouse-Munster Brace in the Treatment of Adolescent Idiopathic Scoliosis on Respiratory Function
- ClinicalTrials.gov ID
- NCT05749562
- Acronym / sponsor ID
- CTM biomec / PO23019*
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent, Female, Biomechanical Phenomena
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 1 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.
This study intends to investigate the effect of bracing on respiratory function in the treatment of adolescent idiopathic scoliosis (AIS). In particular, it will look at the effect of the brace on respiratory function and 3D volume of the thoracic cage. An additional evaluation of the pressure forces of the brace, using a connected t-shirt, will be carried out. The investigators hypothesise that the brace will decrease the respiratory parameters and 3D volume of the thoracic cage, especially during deep breathing.
Detailed description
Scoliosis is a 3D deformity of the spine with curvatures occurring in the three planes of space.
The brace is widely used for adolescent idiopathic scoliosis. The Cheneau-Toulouse-Munster (CTM) brace is a rigid brace, classically indicated for thoracic and lumbar curves. However, scoliosis induces structural deformation of the rib cage. This can lead to changes in thoracic volume associated with a respiratory disorder, mainly restrictive. But the effect of bracing on pulmonary function currently remains unclear.
Few studies in the literature have looked at the impact of the brace on lung function. In those studies, the findings were based on Pulmonary Function Test (PFT) results only. In the CTM biomec study, the investigators propose to evaluate lung function by PFT associated with biplanar radiography using EOS® system, which allows 3D modelling of the rib cage. An additional evaluation of the pressure forces of the CTM brace, using a connected t-shirt, will be carried out to better understand the biomechanics of the brace. It will allow us to observe the stress surfaces on the thorax during the respiratory cycle and to compare them with the adaptation kinematics of the thoracic cage.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Idiopathic Scoliosis with right thoracic or thoraco-lumbar curvature | – | Device: Cheneau-Toulouse-Munster bracePatients will be treated with a Cheneau-Toulouse-Munster (CTM) brace, with a wearing time of more than 12 hours/24h, for more than 1 month. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will be conducted with patients treated for scoliosis in the Department of Pediatric Surgery, at the American Memorial Hospital, CHU Reims.
Key inclusion criteria (6 listed)
- Adolescent girls aged 12 to 16
- With a right thoracic or thoraco-lumbar curvature (right and left)
- With a Cobb angle between 20 and 40°.
- Treated with a Cheneau-Toulouse-Munster brace for more than 1 month
- With a duration of brace wearing of more than 12/24h
Key exclusion criteria (5 listed)
- Male gender
- Having a secondary scoliosis (neuromuscular, syndromic, post-traumatic, congenital pathology)
- Having a respiratory pathology prior to the diagnosis of scoliosis
- Have a history of spinal surgery
- Having already benefited from a brace treatment
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 |
|---|---|---|
| Cheneau-Toulouse-Munster braceFull length, orthogonal anteroposterior and lateral X-rays will be taken with the Cheneau-Toulouse-Munster brace. | Device | Adolescent Idiopathic Scoliosis with right thoracic or thoraco-lumbar curvature |
Primary outcome
Total Lung Capacity (TLC)
Time frame: 1 day
change with and without the brace
1 secondary outcome
Forced expiratory volume in one second
Time frame: 1 day
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 20 Mar 2024.
- 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.
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 Adolescent Idiopathic Scoliosis, run by CHU de Reims at 1 site in France.
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 6 inclusion and 5 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 20 Mar 2024. 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 France. 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?
Total Lung Capacity (TLC) (time frame: 1 day). 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 20 Mar 2024.