Bracing in adolescent idiopathic scoliosis trial

ISRCTN	ISRCTN81733841
DOI	https://doi.org/10.1186/ISRCTN81733841
ClinicalTrials.gov number	NCT00448448
Secondary identifying numbers	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

Not provided at time of registration

Study website

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

Study design	Blinded (outcome assessor), randomised parallel assignment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material on http://www.goosetowngraphics.com/braist/index.htm
Scientific title	Bracing in Adolescent Idiopathic Scoliosis Trial
Study acronym	BrAIST
Study hypothesis	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
Condition	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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.
Secondary outcome measures	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
Overall study start date	01/04/2007
Overall study end date	01/04/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	449
Participant 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
Participant 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
Recruitment start date	01/04/2007
Recruitment end date	01/04/2012

Locations

Countries of recruitment

Canada
United States of America

Study participating centre

The Hospital for Sick Children

Toronto
M5G 1X8
Canada

Sponsor information

The Hospital for Sick Children (Canada)
Hospital/treatment centre

555 University Avenue
Toronto
M5G 1X8
Canada

Website	http://www.sickkids.ca/
"ROR"	https://ror.org/057q4rt57

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (ref: MCT-81050)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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