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

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: Intelligent Nighttime Brace

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanne Yip, phd; Phone Number: 4848 852-27665111; Email: joanne.yip@polyu.edu.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Joanne Yip, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the in-brace Cobb angle	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).	2 hours and 6 months after wearing the brace

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contour control	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.	6 months
Force measurements and monitoring	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.	6 months
Health-related quality of life (SRS-22)	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.	6 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Joanne Yip, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Scoliosis, Bracing Treatment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: ITS/007/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No