Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by The University of Hong Kong.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Scoliosis Research Society

Information provided by:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00989495

First received: October 1, 2009

Last updated: June 25, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 1, 2009
Last Updated Date	June 25, 2010
Start Date ^ICMJE	October 2008
Estimated Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 2, 2009)	Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken. [ Time Frame: Baseline and every four months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00989495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 2, 2009)	SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. [ Time Frame: Baseline and every four months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
Official Title ^ICMJE	Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study
Brief Summary	The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Adolescent Idiopathic Scoliosis
Intervention ^ICMJE	Device: Brace Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
Study Arm (s)	Experimental: Brace - Randomized Intervention: Device: Brace No Intervention: Observation - Randomized Experimental: Brace - preference based Intervention: Device: Brace No Intervention: Observation - preference-based
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	October 2010
Estimated Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of AIS Age ≥10 years Risser sign 0-2 Cobb's angle 20 deg to <25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to <30 deg Exclusion Criteria: History of treatment of AIS >= 1 year postmenarchal (for girls only) Physical or mental disability to adhere to bracing Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace) Difficulty to read, understand, and complete the study questionnaires Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Gender	Both
Ages	10 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT00989495
Other Study ID Numbers ^ICMJE	dytfong, HKCTR-819
Has Data Monitoring Committee	No
Responsible Party	Daniel Y.T. Fong, The University of Hong Kong
Study Sponsor ^ICMJE	The University of Hong Kong
Collaborators ^ICMJE	Scoliosis Research Society
Investigators ^ICMJE	Not Provided
Information Provided By	The University of Hong Kong
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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