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

December 1, 2014 updated by: Dr Daniel Yee Tak FONG, The University of Hong Kong

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has been completed.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The Duchess of Kent Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brace - Randomized
Participants were randomized to be braced
Device: Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
No Intervention: Observation - Randomized
Participants were randomized to be observed only
Experimental: Brace - preference based
Participants chose to be braced
Device: Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
No Intervention: Observation - preference-based
Participants chose to be observed only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and every four months

Secondary Outcome Measures

Outcome Measure
Time Frame
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.
Time Frame: Baseline and every four months
Baseline and every four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Scoliosis Research Society

Investigators

  • Principal Investigator: Daniel YT Fong, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dytfong
  • HKCTR-819 (Registry Identifier: Hong Kong Clinical Trials Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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