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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05790031
• Other study ID #: ITS/007/22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Cobb angle measurements of intelligent nighttime brace	Measure lateral curvature of vertebra on spine x-ray AP view (unit: degree) will be measured by using EOS® low does x-ray.	2 hours after wearing the brace and 6 months
Secondary	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
Secondary	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
Secondary	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