Back to resultsComprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Brace
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring AIS
Eligibility Criteria
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
Sites / Locations
- The Duchess of Kent Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Brace - Randomized
Observation - Randomized
Brace - preference based
Observation - preference-based
Arm Description
Participants were randomized to be braced
Participants were randomized to be observed only
Participants chose to be braced
Participants chose to be observed only
Outcomes
Primary Outcome Measures
Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.
Secondary Outcome Measures
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.
Full Information
NCT ID
NCT00989495
First Posted
October 1, 2009
Last Updated
December 1, 2014
Sponsor
The University of Hong Kong
Collaborators
Scoliosis Research Society
1. Study Identification
Unique Protocol Identification Number
NCT00989495
Brief Title
Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
Official Title
Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Scoliosis Research Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
The study has been completed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
AIS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brace - Randomized
Arm Type
Experimental
Arm Description
Participants were randomized to be braced
Arm Title
Observation - Randomized
Arm Type
No Intervention
Arm Description
Participants were randomized to be observed only
Arm Title
Brace - preference based
Arm Type
Experimental
Arm Description
Participants chose to be braced
Arm Title
Observation - preference-based
Arm Type
No Intervention
Arm Description
Participants chose to be observed only
Intervention Type
Device
Intervention Name(s)
Brace
Intervention Description
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.
Time Frame
Baseline and every four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel YT Fong, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Duchess of Kent Children's Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
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