Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Scoliosis Research Society
Information provided by (Responsible Party):
Dr Daniel Yee Tak FONG, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00989495
First received: October 1, 2009
Last updated: December 1, 2014
Last verified: December 2014

October 1, 2009
December 1, 2014
October 2008
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00989495 on ClinicalTrials.gov Archive Site
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. [ Time Frame: Baseline and every four months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study
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).
The study has been completed.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Adolescent Idiopathic Scoliosis
Device: Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
  • Experimental: Brace - Randomized
    Participants were randomized to be braced
    Intervention: Device: Brace
  • No Intervention: Observation - Randomized
    Participants were randomized to be observed only
  • Experimental: Brace - preference based
    Participants chose to be braced
    Intervention: Device: Brace
  • No Intervention: Observation - preference-based
    Participants chose to be observed only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
November 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of AIS
  2. Age ≥10 years
  3. Risser sign 0-2
  4. 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:

  1. History of treatment of AIS
  2. >= 1 year postmenarchal (for girls only)
  3. Physical or mental disability to adhere to bracing
  4. Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
  5. Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
  6. Difficulty to read, understand, and complete the study questionnaires
  7. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Both
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00989495
dytfong, HKCTR-819
No
Not Provided
Not Provided
Dr Daniel Yee Tak FONG, The University of Hong Kong
The University of Hong Kong
Scoliosis Research Society
Principal Investigator: Daniel YT Fong, PhD The University of Hong Kong
The University of Hong Kong
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP