Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
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|ClinicalTrials.gov Identifier: NCT03617120|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : January 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Device: Ergonomic Brace vs hard brace||Not Applicable|
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.
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis|
|Actual Study Start Date :||August 1, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: 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.
Device: Ergonomic Brace vs hard brace
- 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)
- Immediate in-brace correction of vertebral rotation assessed by the Global Torsion Index [ Time Frame: 2 hours ]
Global torsion index: to quantify detorsion by averaging the 17 segmental rotations of thoracic and lumbar vertebrae
- Higher index score = the average segmental rotations of the 17 vertebrae is higher;
- Lower index score = the average segmental rotations of the 17 vertebrae is lower
The global torsion index which result from wearing the Ergonomic Brace will be compared with which of hard brace. A higher/similar detorsion percentage as hard brace is considered satisfactory.
- Immediate in-brace correction of trunk listing assessed by the plumb line method [ Time Frame: 2 hours ]
Plumb line method: to assess the coronal and sagittal balance by drawing a vertical line from the mid-point of the C7 vertebra down to the sacrum
- Positive balance: the plumb line passes more than 2 cm in front of the posterosuperior corner of the S1 vertebral body
- Neutral balance: the plumb line passes within 2 cm of the posterosuperior corner of the S1 vertebral body
- Negative balance: the plumb line passes more than 2 cm behind the posterosuperior corner of the S1 vertebral body
Measurement of trunk listing is significant in the treatment of scoliosis curve, as it is related to the trunk aesthetic profile of the subjects, and besides, sagittal balance of the spine and pelvis is correlated with the progression of scoliosis. An improvement in the coronal and sagittal balance of spine resulting from wearing the Ergonomic Brace is therefore considered satisfactory.
- Improvement in trunk asymmetry assessed by the POTSI index [ Time Frame: 0 and 6 month ]
Posterior Trunk Symmetry Index (POTSI): to compare the surface topography change before and after wearing the Ergonomic Brace POTSI index: a parameter used for assessing the trunk asymmetry and deformity in the coronal plane All measurements will be performed on the 3D surface topography scans. Ideal value of POTSI is zero, meaning full asymmetry of the posterior and anterior trunk respectively.
Normal value of POTSI should lie below 27. The performance of the Ergonomic Brace in terms of improving the trunk asymmetry of participants is considered effective when the index is scored within normal value (i.e. 0-27).
- Improvement in trunk asymmetry assessed by the ATSI index [ Time Frame: 0 and 6 month ]Anterior Trunk Symmetry Index (ASTI): to compare the surface topography change before and after wearing the Ergonomic Brace ATSI index: a parameter used for assessing the trunk asymmetry and deformity in the frontal plane All measurements will be performed on the 3D surface topography scans. Ideal value of ATSI is zero, meaning full asymmetry of the posterior and anterior trunk respectively. Normal value, on the other hand, should lie below 27 for each index. The performance of the Ergonomic Brace in terms of improving the trunk asymmetry of participants is considered effective when the index is scored within normal value (i.e. 0-27).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617120
|Contact: Joanne Yip||(852) 2766 firstname.lastname@example.org|
|The Hong Kong Polytechnic University||Recruiting|
|Tsim Sha Tsui, Kolwoon, Hong Kong, 00852|
|Contact: Joanne Yip, PhD 85227664848 email@example.com|
|Contact: Kit Yick, PhD 85227666551 firstname.lastname@example.org|
|Principal Investigator:||Joanne Yip||The Hong Kong Polytechnic University|