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Clinical Trials in China / NCT05790031
Recruiting Not applicable

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

NCT05790031 · tracked via the Priya Life Science China tracker
Sponsor
The Hong Kong Polytechnic University
Phase
Not applicable
Started
2023-09-01
Last updated
2024-10-15

Condition(s) studied

Adolescent Idiopathic Scoliosis

Investigational drug(s) / intervention(s)

Intelligent Nighttime Brace

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

Study 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.

Eligibility

Sex
FEMALE
Min age
10 Years
Max age
13 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Investigate the in-brace Cobb angle — 2 hours and 6 months after wearing the brace
    1\. Number of Participants Maintaining Cobb Angle Stability (\<5° Increase) After Wearing the Brace for 2 Hours, as Measured by Spine X-ray (AP View).

Trial sites (1)

FacilityCityRegionStatus
The Hong Kong Polytechnic University Hong Kong China Recruiting

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Other trials for the same condition

3D Depth Camera-Based Assessment of Adolescent Idiopathic ScoliosisUsing a Depth Camera Recruiting
Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis Recruiting
Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of AIS Based on Epigene-phenotype Starting soon
Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05790031 on ClinicalTrials.gov ↗ ← All trials in China