Bracing in adolescent idiopathic scoliosis trial

ISRCTN	ISRCTN81733841
DOI	https://doi.org/10.1186/ISRCTN81733841
ClinicalTrials.gov (NCT)	NCT00448448
Protocol serial number	MCT-81050
Sponsor	The Hospital for Sick Children (Canada)
Funder	Canadian Institutes of Health Research (ref: MCT-81050)

Submission date: 04/07/2008
Registration date: 04/07/2008
Last edited: 11/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr James Gardner Wright
Scientific

Department of Surgery
The Hospital for Sick Children
555 University Avenue
Toronto
M5G 1X8
Canada

Phone	+1 (0)416 813 6433
Email	james.wright@sickkids.ca

Ms Magdalena Lysenko
Public

Clinical Research Coordinator
Hospital for Sick Children
555 University Avenue
Toronto
M5G 1X8
Canada

Email	magdalena.lysenko@sickkids.ca

Study information

Primary study design	Interventional
Study design	Blinded (outcome assessor), randomised parallel assignment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Bracing in Adolescent Idiopathic Scoliosis Trial
Study acronym	BrAIST
Study objectives	Bracing is an effective, non-operative treatment for adolescent idiopathic scoliosis.
Ethics approval(s)	Research Ethics Board of the Hospital for Sick Children (Toronto), 19/04/2004, ref: 1000010719
Health condition(s) or problem(s) studied	Adolescent idiopathic scoliosis
Intervention	Amended as of 06/03/2009: Bracing arm: Thoracolumbar spinal orthosis, worn daily until skeletal maturity or curve progression to 50 degrees Watchful waiting arm: Physician evaluation every 6 months until skeletal maturity or curve progression to 50 degrees Initial information at the time of registration: Bracing arm: Thoracolumbar spinal orthosis, worn daily until skeletal maturity or curve progression greater than 45 degrees Watchful waiting arm: Physician evaluation every 6 months until skeletal maturity or curve progression greater than 45 degrees
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Amended as of 06/03/2009: Progression to 50 degrees as measured every 6 months. Initial information at the time of registration: Progression to greater than 45 degrees as measured every 6 months.
Key secondary outcome measure(s)	1. Child Health Questionnaire measured every 6 months 2. Self-Image Questionnaire for Young Adolescents measured every 6 months 3. Peds Quality of Life measured every 6 months 4. Spinal Appearance Questionnaire measured every 6 months
Completion date	01/04/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	449
Key inclusion criteria	Amended as of 06/03/2009: 5. Primary Cobb angle 20 - 39 degrees Initial information at the time of registration: 1. Diagnosis of adolescent idiopathic scoliosis 2. Aged 10 - 15 years, either sex 3. Risser 0 - 2 4. Menarche within 1 year 5. Primary Cobb angle 25 - 39 degrees 6. Curve Apex caudal to T7
Key exclusion criteria	1. Other musculoskeletal, neurological, or developmental illnesses possibly responsible for the curvature 2. Physical and mental disability precluding adherence to bracing protocol 3. History of previous surgical or orthotic treatment 4. Inability to read and understand English, Spanish, and/or French
Date of first enrolment	01/04/2007
Date of final enrolment	01/04/2012

Locations

Countries of recruitment

Canada
United States of America

Study participating centre

The Hospital for Sick Children

Toronto
M5G 1X8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/10/2013	11/04/2019	Yes	No
Protocol article	protocol	01/10/2013		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2019: Publication reference added.
24/03/2016: added link to results - basic reporting.