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Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

RecruitingNAAges 10 Years - 14 YearsFemaleThe Hong Kong Polytechnic University
NCT02589106 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological conce

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 10 to 14 years * Diagnosis of AIS * a Cobb's angle between 20 to 30 degrees * a Risser grade of the iliac crest of ≤ 2 * Pre-menarche or post- menarche by no more than 1 year * Ability to read and understand English or Chinese * Physical and mental ability to adhere to anisotropic textile braces protocol Exclusion Criteria: * Contraindications for x-ray exposure * Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature * History of previous surgical or orthotic treatment for AIS * Contraindications for pulmonary and/ or exercise tests * Psychiatric disorders * Recent trauma * Recent traumatic (emotional) event
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What it tests

  • Anisotropic Textile Braces
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Where

2 sites
The Hong Kong Polytechnic University
Hong Kong, China
The Hong Kong Polytechnic University
Hong Kong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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