UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062171 |
|---|---|
| Receipt number | R000071147 |
| Scientific Title | A Randomized Controlled Trial Comparing Cheneau Brace and Conventional Underarm Thoracolumbosacral Orthosis for the Treatment of Adolescent Idiopathic Scoliosis |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/08 16:50:21 |
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Basic information
Public title
A Randomized Controlled Trial Comparing Cheneau Brace and Underarm Thoracolumbosacral Orthosis for Adolescent Idiopathic Scoliosis
Acronym
AIS Bracing RCT
Scientific Title
A Randomized Controlled Trial Comparing Cheneau Brace and Conventional Underarm Thoracolumbosacral Orthosis for the Treatment of Adolescent Idiopathic Scoliosis
Scientific Title:Acronym
AIS Bracing RCT
Region
| Japan |
Condition
Condition
Adolescent Idiopathic Scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the treatment outcomes of the new Cheneau brace with those of the conventional underarm brace in patients with adolescent idiopathic scoliosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients achieving an improvement of 6 degrees or more in the Cobb angle at the end of brace treatment in each treatment group.
Key secondary outcomes
The proportion of patients whose Cobb angle progression was limited to 5 degrees or less at the end of brace treatment.
Factors associated with favorable brace treatment outcomes.
Differences in SRS-22 and BSSQ-Brace scores between the two treatment groups.
Differences in brace compliance between the two treatment groups.
Differences in the incidence of brace-related complications between the two treatment groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with adolescent idiopathic scoliosis who are eligible for brace treatment will be randomly assigned to either a conventional underarm thoracolumbosacral orthosis or a Cheneau brace, which is widely used in Europe and North America, to compare the safety and efficacy of the two braces.
Interventions/Control_2
A button-shaped temperature sensor will be attached to each brace to objectively monitor brace compliance.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 10 to 16 years at the time of informed consent.
2. Outpatients diagnosed with adolescent idiopathic scoliosis (AIS).
3. Patients who meet the indications for brace treatment, defined as a Risser grade of 4 or less, a Cobb angle of 25 degrees or greater (or 20 degrees or greater in premenarchal patients), and less than 2 years since menarche for postmenarchal patients.
4. Patients who are capable of providing informed consent and are able to provide written informed consent voluntarily. For patients younger than 18 years of age, written informed consent must also be obtained from a legally authorized representative.
5. Patients who, in the judgment of the principal investigator or sub-investigator, are considered suitable for participation in this study and for the evaluation of its efficacy and safety after consideration of the inclusion and exclusion criteria.
Key exclusion criteria
1. Patients with a Cobb angle of 40 degrees or greater.
2. Patients who do not provide written informed consent to participate in this randomized controlled trial.
3. Patients who have psychiatric disorders or lack the capacity to provide informed consent.
4. Patients who, in the judgment of the principal investigator, are considered unsuitable for participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Nojiri |
Organization
Juntendo University Faculty of Medicine, Juntendo University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3818-3111
hnojiri@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Juri |
| Middle name | |
| Last name | Teramoto |
Organization
Juntendo University Faculty of Medicine, Juntendo University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3818-3111
Homepage URL
j-ooka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Faculty of Medicine, Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-3813-3111
j-ooka@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071147
