Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis

The Hong Kong Polytechnic University

Status: Completed

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Device: Ergonomic Brace vs hard brace

Study type: Interventional

Funder types: Other

Identifiers

NCT03617120

ITS/297/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Ergonomic Brace vs hard brace

Experimental group

Description:

Ergonomic Brace is a new design of scoliosis brace, which consists of a knit bodice as base and also resin bones, paddings, straps and a pelvic belt as auxiliaries for spinal correction. The purpose of the bones is to keep the posture of patient upright. Paddings are placed at the convex regions of the spine while straps are used to input directional force onto the paddings. Pelvic belt, on the other hand, is for stabilizing the pelvis in order to achieve an effective spinal correction. The biomechanical principles for the correction of spine has considered both the frontal and sagittal planes, where the overall brace mechanism follows the Rigo classification. Hard brace is the brace which the participants are currently using for their ongoing conservative treatment.

Treatment:

Device: Ergonomic Brace vs hard brace