Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis

Launched by THE HONG KONG POLYTECHNIC UNIVERSITY · Mar 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new type of nighttime brace designed to help treat Adolescent Idiopathic Scoliosis (AIS), which is a condition where the spine curves abnormally during adolescence. The goal of the trial is to see if this intelligent brace can effectively prevent the worsening of the spinal curve while allowing teenagers to maintain their daily activities, as it is meant to be worn while sleeping. Researchers are particularly interested in how this specialized brace can improve comfort and control over how it corrects the spine compared to traditional braces.

To participate in this study, girls aged 10 to 13 who have a mild to moderate spinal curve (measured by a technique called the Cobb angle) and have not received any prior treatment for scoliosis may be eligible. Participants should be able to understand instructions in English or Chinese and have the physical and mental ability to follow the study guidelines. Those with a history of surgery for scoliosis, other serious health issues affecting the spine, or certain mental health conditions will not qualify. If they join the study, participants can expect to wear the brace at night and will be monitored to assess its effectiveness.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. between the ages of 10-13,
• • 2. scoliosis with a Cobb angle larger between 10 -25 degrees;
• • 3. No prior treatment
• • 4. Pre-menarche or post- menarche by no more than 1 year
• • 5. Ability to read and understand English or Chinese
• • 6. Physical and mental ability to adhere to intelligent nighttime braces protocol
• Exclusion Criteria:
• • 1. History of previous surgical or orthotic treatment for AIS
• • 2. Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
• • 3. Contraindications for pulmonary and/ or exercise tests
• • 4. Psychiatric disorders
• • 5. Recent trauma