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Search / Trial NCT03716843

Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Launched by THE HONG KONG POLYTECHNIC UNIVERSITY · Oct 20, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Dynamic Pressure Monitoring

ClinConnect Summary

This clinical trial is studying a new system called the Dynamic Pressure Monitoring System, which aims to improve the treatment of Adolescent Idiopathic Scoliosis (AIS), a condition where the spine curves in an unusual way in teenagers aged 10 to 16. Traditional braces can cause problems like skin irritation and pressure sores because they don’t always distribute pressure evenly. The new system will measure how pressure is applied between the brace and the body to make brace treatment more effective and comfortable, helping to reduce the risks of skin injuries.

To participate in this trial, applicants should be teenagers diagnosed with AIS and have a spinal curve (measured by the Cobb angle) between 25 to 45 degrees. They should also have an immature skeleton, meaning they are still growing. However, those who have had previous surgeries for scoliosis, certain other health conditions, or issues that prevent them from having X-rays won’t be eligible. Participants will wear the brace and have their pressure distribution monitored, which should help improve their treatment experience and outcomes.

Gender

ALL

Eligibility criteria

  • 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

About The Hong Kong Polytechnic University

The Hong Kong Polytechnic University (PolyU) is a leading institution in applied research and education, dedicated to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, PolyU focuses on conducting rigorous and ethically sound research to enhance understanding of medical interventions and improve patient outcomes. The university leverages its multidisciplinary expertise, state-of-the-art facilities, and collaboration with industry partners to facilitate groundbreaking studies that address pressing health challenges. Committed to fostering an environment of academic excellence, PolyU aims to translate research findings into practical solutions that benefit society and contribute to the global advancement of healthcare.

Locations

Tsim Sha Tsui, Kolwoon, Hong Kong

Patients applied

0 patients applied

Trial Officials

Joanne Yip, PhD

Principal Investigator

The Hong Kong Polytechnic University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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