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
2 other identifiers
interventional
68
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 3, 2014
December 1, 2014
2.4 years
October 1, 2009
December 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.
Baseline and every four months
Secondary Outcomes (1)
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.
Baseline and every four months
Study Arms (4)
Brace - Randomized
EXPERIMENTALParticipants were randomized to be braced
Observation - Randomized
NO INTERVENTIONParticipants were randomized to be observed only
Brace - preference based
EXPERIMENTALParticipants chose to be braced
Observation - preference-based
NO INTERVENTIONParticipants chose to be observed only
Interventions
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Scoliosis Research Societycollaborator
Study Sites (1)
The Duchess of Kent Children's Hospital
Hong Kong, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel YT Fong, PhD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 1, 2009
First Posted
October 5, 2009
Study Start
October 1, 2008
Primary Completion
March 1, 2011
Study Completion
November 1, 2011
Last Updated
December 3, 2014
Record last verified: 2014-12