Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adolescent Idiopathic Scoliosis
- Sponsor
- The Hong Kong Polytechnic University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Immediate in-brace correction of spinal curve
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects:
- To assess the efficacy in spinal correction
- To evaluate the improvement made to the body appearance of AIS subjects
- To evaluate the impacts on the quality of life (QoL) of AIS subjects
All participants will be fitted with an Ergonomic Brace and required to wear it during the days of experiment only. The ongoing treatment with hard brace will not be substituted with the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.
Detailed Description
1. To assess the efficacy in spinal correction The efficacy of the Ergonomic Brace refers to the magnitude of spinal correction that could be obtained for patients with AIS. The assessments in this study focus on two aspects, which are i) the in-brace correction and ii) the interface pressure. In-brace correction is used to judge the quality of bracing and also a prognostic indicator for the long-term treatment outcome. Clinical parameters such as Cobb angle, vertebral rotation and trunk listing will be measured with radiographs by a single observer. Interface pressure in this study refers to the pressure between the brace and the trunk of subject. The purpose is to assess the time response of trunk to the intervention of the Ergonomic Brace, and correlation will also be made with the extent of spinal correction. 2. To evaluate the improvement made to the body appearance of AIS subjects The trunk aesthetic profile of AIS subjects are being affected by spinal deformities. Surface topography of the subjects will be captured by 3D body scanner, and followed by the evaluation of body aesthetics through the trunk asymmetry scales called POTSI and ATSI index. The purpose is to compare the surface topography change before and after wearing the Ergonomic Brace. 3. To evaluate the impacts on the QoL of AIS subjects Bracing can negatively affect the QoL of patients with AIS. The Chinese version of Brace Questionnaire (BrQ) will be adopted in this study to compare the impact of hard brace and Ergonomic Brace on the QoL of AIS subjects. Difficulties experienced by AIS subjects during bracing will be highlighted and used for future improvements in scoliosis brace design.
Investigators
Joanne Yip
Assistant Professor
The Hong Kong Polytechnic University
Eligibility Criteria
Inclusion Criteria
- •Age 10 or older when brace is prescribed
- •Risser 0 to 2
- •Primary curve angles 25° to 40°
- •Female, who were either pre-menarche or less than 1 year of post-menarche
- •Undergoing hard brace treatment
Exclusion Criteria
- •Low risk of curve progression
- •Non-idiopathic scoliosis (e.g. congenital, neuromuscular deformities)
Outcomes
Primary Outcomes
Immediate in-brace correction of spinal curve
Time Frame: 2 hours
Cobb angle: more than/equal to 40% correction (lumbar/thoracolumbar curve); slightly less than/close to 40% correction (thoracic curve)
Secondary Outcomes
- Immediate in-brace correction of vertebral rotation assessed by the Global Torsion Index(2 hours)
- Improvement in trunk asymmetry assessed by the ATSI index(0 and 6 month)
- Improvement in trunk asymmetry assessed by the POTSI index(0 and 6 month)
- Immediate in-brace correction of trunk listing assessed by the plumb line method(2 hours)