Viewing Study NCT05790031



Ignite Creation Date: 2024-05-06 @ 6:49 PM
Last Modification Date: 2024-10-26 @ 2:55 PM
Study NCT ID: NCT05790031
Status: RECRUITING
Last Update Posted: 2023-09-25
First Post: 2023-03-16

Brief Title: Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Sponsor: The Hong Kong Polytechnic University
Organization: The Hong Kong Polytechnic University

Study Overview

Official Title: Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None