NCT03617120

Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

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: 1. To assess the efficacy in spinal correction 2. To evaluate the improvement made to the body appearance of AIS subjects 3. 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.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	Ergonomic Brace vs hard brace	Visit 1: 1. Usual check-up: standing in-brace radiograph of hard brace and doctor consultation 2. Pressure measurement of participant wearing their hard brace Visit 2: 1. Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS) 2. 3D body scanning (before wearing the Ergonomic Brace) 3. Fitting of the Ergonomic Brace 4. Pressure measurement of participant wearing the Ergonomic Brace (instant) 5. Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours) 6. 3D body scanning (after wearing the Ergonomic Brace for 2 hours) 7. Brace Questionnaire (BrQ) for the Ergonomic Brace Visit 3: 1. Standing in-brace radiograph of the Ergonomic Brace 2. Doctor consultation

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-12-31
• Completion: 2020-01-31
• First posted: 2018-08-06
• Last updated: 2020-02-12

Locations

1 site across 1 country: Hong Kong