Clinical Trial

Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Recruiting
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2018-10-20; most recent amendment 2024-10-16.
Status change: Not Yet Recruiting → Recruiting 2022-08-14
Trial Details
NCT Number NCT03716843
Lead Sponsor The Hong Kong Polytechnic University
Collaborators: Washington University School of Medicine, The University of Hong Kong
Conditions Adolescent Idiopathic Scoliosis
Enrollment 20 participants
Start Date 2022-01-02
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-18