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

NCT ID: NCT05790031

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2028-12-31

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

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Intelligent Nighttime Brace

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Joanne Yip

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanne Yip, phd

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Joanne Yip, phd

Role: CONTACT

joanne.yip@polyu.edu.hk

852-27665111 ext. 4848

Facility Contacts

Joanne Yip, phd

Role: primary

Other Identifiers

ITS/007/22

Identifier Type: -

Identifier Source: org_study_id