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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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 m

Первичные конечные точки

• Investigate the in-brace Cobb angle [Срок оценки: 2 hours and 6 months after wearing the brace]

Вторичные конечные точки (3)

• Contour control [Срок оценки: 6 months]
• Force measurements and monitoring [Срок оценки: 6 months]
• Health-related quality of life (SRS-22) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• between the ages of 10-13,
• scoliosis with a Cobb angle larger between 10 -25 degrees;
• No prior treatment
• Pre-menarche or post- menarche by no more than 1 year
• Ability to read and understand English or Chinese
• Physical and mental ability to adhere to intelligent nighttime braces protocol

Критерии исключения

• History of previous surgical or orthotic treatment for AIS
• Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
• Contraindications for pulmonary and/ or exercise tests
• Psychiatric disorders
• Recent trauma

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT05790031 · ITS/007/22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗