About this trial
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 evaluated, and the maximum compressive stresses that patients can endure on different body parts without pressure injury can be computed.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pressure monitoring system
Treatment groups
Sponsors and collaborators
The Hong Kong Polytechnic University
Lead sponsor
Washington University School of Medicine
Collaborator
The University of Hong Kong
Collaborator