Clinical trial NCT03617120: Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
Official title: Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis brace
Conventional treatment for Adolescent Idiopathic Scoliosis
In-brace correction
Trunk listing
Vertebral rotation
Interface pressure
3D body scanning
Surface topography
Trunk asymmetry
Quality of Life
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Innovation and Technology Commission, Hong Kong
name: The University of Hong Kong
First posted: 2018-08-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Immediate in-brace correction of spinal curve
timeFrame: 2 hours
Secondary outcomes:
measure: Immediate in-brace correction of vertebral rotation assessed by the Global Torsion Index
timeFrame: 2 hours
measure: Immediate in-brace correction of trunk listing assessed by the plumb line method
timeFrame: 2 hours
measure: Improvement in trunk asymmetry assessed by the POTSI index
timeFrame: 0 and 6 month
measure: Improvement in trunk asymmetry assessed by the ATSI index
timeFrame: 0 and 6 month
Other outcomes:
Locations:
city: Tsim Sha Tsui
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kolwoon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Joanne Yip
role: PRINCIPAL_INVESTIGATOR
References: