NCT05790031

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 10 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.

Detailed description

The design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as 1. compression and pulling forces through a customizable rigid brace 2. lumbar flexion by using a supporting air-belt. 3. three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction 4. adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	Intelligent Nighttime Brace	Participants will be invited to undergo a fitting session of intelligent nighttime brace. After the fitting, participants will join a 6-month wear trial of the intelligent nighttime brace. Participants are required to wear the intelligent nighttime brace for 8 hours a day during sleeping and compliance will be recorded by an intelligent monitoring system. Participants will be invited to undergo assessments before the wear trial, after the trials of 3 months and after the trial of 6 months. The measure outcomes of the assessment include 1)ultrasound scanning image, 2)3D body scanning, 3)garment pressure, 4) questionnaires

Timeline

• Start date: 2023-09-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2023-03-29
• Last updated: 2024-10-15

Locations

1 site across 1 country: China