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Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Recruitingn/aAges 10 Years - 15 YearsAllThe Hong Kong Polytechnic University
NCT03716843 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Adolescent idiopathic scoliosis (AIS) involves three-dimensional spinal deformity in children aged between 10 and 16. Traditional braces modify the natural dynamics and thus the mechanical behaviour of the scoliotic spine through external constraints. Patients usually develop pressure ulcers and skin irritation when prescribed brace treatment for 18-23 hours per day. The excessive pressure, unknown pressure distribution and pressure shifting between the human body and the brace causes the effects of brace treatment to be unpredictable. Dynamic pressure monitoring system will be developed based on the body landmarks of scoliotic patients and critical areas where active pressure is applied by the brace. The overall pressure distribution and dynamic pressure between the body and the thoraco-lumbo-sacral orthosis (TLSO) rigid brace will be measured. The efficacy of the brace design will be e

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📋 Eligibility rules (as published)
Inclusion Criteria: * Teenagers diagnosed with adolescent idiopathic scoliosis * Cobb's angle between 25 to 45 degrees * Immature skeletons (Risser grade 0-2) * Types of scoliosis are classified by the Lenke classification system * Have received rigid brace treatment 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 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

  • Pressure monitoring system
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Where

1 site
The Hong Kong Polytechnic University
Tsim Sha Tsui, Hong Kong
🤝 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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