Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis

NCT ID: NCT03617120

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-01-31

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:

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ergonomic Brace vs hard brace

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.

Group Type: EXPERIMENTAL

Ergonomic Brace vs hard brace

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Innovation and Technology Commission, Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Joanne Yip

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanne Yip

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Tsim Sha Tsui, Kolwoon, Hong Kong

Countries

Hong Kong

Other Identifiers

ITS/297/16

Identifier Type: -

Identifier Source: org_study_id