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

Not Applicable

Recruiting

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Device: Intelligent Nighttime Brace

• Registration Number: NCT05790031
• Lead Sponsor: The Hong Kong Polytechnic University

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 Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Study Start: 2023-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-15
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intelligent Nighttime Brace	Intelligent Nighttime Brace	The design of intelligent nighttime brace will incorporate different mechanism, such as a) compression and pulling forces through a customisable rigid brace, b) lumbar flexion by using a supporting air-belt, c) three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction, d) adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Force measurements and monitoring	6 months	Measure the brace interface pressure by the Novel Pliance-xf-16 analyser. The bio-mechanics of the intelligent nighttime brace are assessed by the changes of the pressure distribution. A real-time intelligent system is use to monitor the pressure distribution.
Contour control	6 months	Use a 3D body scanner to measure the contour asymmetry. By using 3D scanning images, the contour asymmetry changes over a six-month period will be assessed.
Health-related quality of life (SRS-22)	6 months	Measure the quality of life by validated questionnaire, Euroqol (EQ-5D-5L). The five dimensions of the descriptive system are mobility, self-care, regular activities, pain/comfort, and anxiety/depression. The patients with higher values represent a worse outcome.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇨🇳 Hong Kong, China