Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

Официальное название

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Обзор

Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spine curvature increases in youths as puberty progresses. Generally, only observation is suggested for adolescents with early scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. Flexible brace treatment is an alternative option; however, its efficacy is still controversial. Posture correction girdle with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. A scientific approach should be used to design and develop posture correction girdle as a treatment option for adolescents with early scoliosis.

Подробное описание

The design of posture correction girdle will incorporate different mechanisms, such as

1. compression and pulling forces through a close fit of the intimate apparel 2. lumbar flexion by using a supporting belt 3. transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system 4. axial rotation or coupled motion by using a system with uneven straps, and 5. an active mechanism that aims to shift the trunk away from areas of pressure.

Вмешательства

• Устройство Posture Correction Girdle
  Participants will be invited to undergo a fitting session of posture correction girdle. After the fitting, participants will join a 6-month wear trial of the posture correction girdle. Participants are required to wear the girdle for 8 hours a day and the compliance will be recorded by a logbook daily. Participants will be invited to undergo assessments before the wear trial, after the trial of 3 months, and after the trial of 6 months. The measure outcomes of the assessment include 1) ultrasoun

Первичные конечные точки

• Effectiveness of posture correction girdle [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Posture improvement [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Diagnosis of AIS
• Cobb's angle 10˚-20˚
• Risser grade ≤ 2
• 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 anisotropic textile braces protocol

Критерии исключения

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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT03332251 · GRF2017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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