Idiopathic ScoliosisCOVIRSCOLNCT03978273
Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients
A study testing Night-time brace + virtual-brace and Night-time brace only in people with Idiopathic Scoliosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls. The treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Night-time brace + virtual-brace and Night-time brace only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2019to Apr 2023
- Phase
- Interventional
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with idiopathic scoliosis (left lumbar or right thoracic),
- Patients with moderate scoliosis: Cobb angle assessed on the last radiography between 20 ° and 35 °,
- Patients requiring the wearing of a rigid night-time brace,
- Patients having a home computer,
- Patients affiliated to social security or similarly regime,
- Patients who gave their consent to participate in the study,
- Patients whose 2 parents have signed the informed consent
Who cannot join
- Patients with an unstabilized medical problem,
- Patients with known allergy to elastane,
- Patients with sensitivity to dizziness,
- Patients with pacemaker,
- Patients with implanted cardiac defibrillator,
- Patients with cochlear implant,
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- Patients carrying a non-removable metal element,
- Protected patient concerned by articles L1121-5 and L1121-6 of the Public Health Code,
- Patients whose parents are protected by article L1121-8 of the Public Health Code
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, 38043
Aurelien COURVOISIER, MD, PhD, Echipon@chu-grenoble.fr
Jacques GRIFFET, MD, PhD
About this study
Official title: Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients: A Prospective, Monocentric, Randomized With Stratification on the Type of Scoliosis, Comparative and Open-label Study
Scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls.
The treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. The place of rehabilitation is disputed because the methods are multiple, non-standardized and the sessions are infrequent.
Read more
In a previous study (MOUVSCO, NTC02134704), researchers have identified systematic postural abnormalities in patients with scoliosis, and developped a virtual-brace (medical device, MD) to allow real-time self-correction of the trunk position.
The aim of the present study is to evaluate for the first time the efficacy of the virtual-brace on the correction of the posture of scoliotic patients.
The hypothesis is that intensified rehabilitation with the virtual-brace will improve pathological postures related to scoliosis.
Read the detailed description
The present study is the first evaluation of the efficacy of the virtual-brace on scoliotic patients.
The efficacy of rehabilitation will be estimate on the correction of the posture of scoliosis patients over 6 months by comparing 2 groups: a control group of patients conventionally treated with a night-time brace (G0 group_conventional) and an experimental group of patients wearing a night-time brace, doing postural rehabilitation exercises with the virtual brace and follow-up visits with a physiotherapist (G1 group_virtual-brace).
- Conditions
- Idiopathic Scoliosis
- Being tested
- Night-time brace + virtual-brace, Night-time brace only
- Keywords
- Vertebral column, Rehabilitation, Virtual-brace, Posture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night-time brace + virtual-braceDevice
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
Additionally :
- They will perform 5 sessions of postural rehabilitation exercises per week (each of 30 minutes) with the virtual-brace (MD).
- They will have also follow up consultations with a physiotherapist every 21 days, to evaluate treatment observance and to adapt postural exercises according to the results and difficulties encountered.
Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.
Night-time brace onlyOther
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.
| Study group | Role | What they receive |
|---|---|---|
| Night-time brace + virtual-brace | Experimental | Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD). Receives: Device: Night-time brace + virtual-brace |
| Night-time brace only | Active comparator | Patients are conventionally treated with night-time brace only. Receives: Other: Night-time brace only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medio-lateral displacement during lateral inclination of scoliosis patients in the group with rehabilitation enriched by the virtual brace (group G1) compared with the reference treatment (group G0) at D180.
Difference between D180 and D0 of the medio-lateral displacement of the pressure center during the lateral inclination in both groups G0 and G1. This parameter is evaluated during the conventional 3D motion capture analysis.
Measured: 6 months
Secondary outcomes (7)
Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).
Conventional 3D motion capture analysis with surface ElectroMyoGram (EMG) pattern's at D0, D90 and D180.
Measured: 6 months
Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.
Difference in the result of the SRS-22 questionnaire between D180 and D0. SRS-22 is a self-reported questionnaire assessing self-image, function, pain, mental health, and satisfaction with care with score range from 1 to 5 (1=worst and 5= best) for each 22 questions. The global score is the mean score of all questions.
Measured: 6 months
Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)
Time course of the angular data of the trunk relative to the pelvis provided by the virtual brace, versus the prescribed exercises (evaluated every 3 weeks during the visit to the physiotherapist)
Measured: 6 months
Treatment compliance for the rigid-brace (for both group G1 and G0)
Compliance with the wearing of the rigid brace reported in the patient follow-up logbook.
Measured: 6 months
Treatment compliance for the virtual-brace (only for group G1)
Only for group G1 : effective rehabilitation time collected from the virtual brace's log files.
Measured: 6 months
Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).
Conventional 3D motion capture analysis with EEG records at D0, D90 and D180.
Measured: 6 months
Exploratory Objective : Descriptive analysis by group of all parameters related to postural disorders recorded during Conventional 3D motion capture analysis with EMG, EEG.
Set of variables related to the severity of the postural disorder.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start11 Oct 2019
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Aurelien COURVOISIER, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978273
- Sponsor's protocol ID
- 38RC18.053
- Acronym
- COVIRSCOL
- Status last verified
- Mar 2020
- First submitted
- 15 May 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients: A Prospective, Monocentric, Randomized With Stratification on the Type of Scoliosis, Comparative and Open-label Study
- ClinicalTrials.gov ID
- NCT03978273
- Acronym / sponsor ID
- COVIRSCOL / 38RC18.053
- Conditions
- Idiopathic Scoliosis
- Keywords
- Vertebral column, Rehabilitation, Virtual-brace, Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, University Grenoble Alps
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 7 Jun 2019 (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.
Scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls.
The treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. The place of rehabilitation is disputed because the methods are multiple, non-standardized and the sessions are infrequent.
In a previous study (MOUVSCO, NTC02134704), researchers have identified systematic postural abnormalities in patients with scoliosis, and developped a virtual-brace (medical device, MD) to allow real-time self-correction of the trunk position.
The aim of the present study is to evaluate for the first time the efficacy of the virtual-brace on the correction of the posture of scoliotic patients.
The hypothesis is that intensified rehabilitation with the virtual-brace will improve pathological postures related to scoliosis.
Detailed description
The present study is the first evaluation of the efficacy of the virtual-brace on scoliotic patients.
The efficacy of rehabilitation will be estimate on the correction of the posture of scoliosis patients over 6 months by comparing 2 groups: a control group of patients conventionally treated with a night-time brace (G0 group_conventional) and an experimental group of patients wearing a night-time brace, doing postural rehabilitation exercises with the virtual brace and follow-up visits with a physiotherapist (G1 group_virtual-brace).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Night-time brace + virtual-brace | Experimental | Device: Night-time brace + virtual-bracePatients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD). |
| Night-time brace only | Active comparator | Other: Night-time brace onlyPatients are conventionally treated with night-time brace only. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients with idiopathic scoliosis (left lumbar or right thoracic),
- Patients with moderate scoliosis: Cobb angle assessed on the last radiography between 20 ° and 35 °,
- Patients requiring the wearing of a rigid night-time brace,
- Patients having a home computer,
- Patients affiliated to social security or similarly regime,
Key exclusion criteria (9 listed)
- Patients with an unstabilized medical problem,
- Patients with known allergy to elastane,
- Patients with sensitivity to dizziness,
- Patients with pacemaker,
- Patients with implanted cardiac defibrillator,
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 |
|---|---|---|
| Night-time brace + virtual-bracePatients will receive conventional treatment : wearing a night-time brace every night during 6 months. Additionally : * They will perform 5 sessions of postural rehabilitation exercises per week (each of 30 minutes) with the virtual-brace (MD). * They will have also follow up consultations with a physiotherapist every 21 days, to evaluate treatment observance and to adapt postural exercises according to the results and difficulties encountered. Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180. | Device | Night-time brace + virtual-brace |
| Night-time brace onlyPatients will receive conventional treatment : wearing a night-time brace every night during 6 months. Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180. | Other | Night-time brace only |
Primary outcome
Medio-lateral displacement during lateral inclination of scoliosis patients in the group with rehabilitation enriched by the virtual brace (group G1) compared with the reference treatment (group G0) at D180.
Time frame: 6 months
Difference between D180 and D0 of the medio-lateral displacement of the pressure center during the lateral inclination in both groups G0 and G1. This parameter is evaluated during the conventional 3D motion capture analysis.
7 secondary outcomes
Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).
Time frame: 6 months
Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.
Time frame: 6 months
Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)
Time frame: 6 months
Treatment compliance for the rigid-brace (for both group G1 and G0)
Time frame: 6 months
Treatment compliance for the virtual-brace (only for group G1)
Time frame: 6 months
Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).
Time frame: 6 months
Exploratory Objective : Descriptive analysis by group of all parameters related to postural disorders recorded during Conventional 3D motion capture analysis with EMG, EEG.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Aurelien COURVOISIER, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night-time brace + virtual-brace and Night-time brace only in people with Idiopathic Scoliosis, run by University Hospital, Grenoble 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 7 inclusion and 9 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 18 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurelien COURVOISIER, MD, PhD (476767313 ext. 0033, Echipon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medio-lateral displacement during lateral inclination of scoliosis patients in the group with rehabilitation enriched by the virtual brace (group G1) compared with the reference treatment (group G0) at D180. (time frame: 6 months). 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 18 Mar 2020.