Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Официальное название

Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Обзор

One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological concerns into consideration.

Подробное описание

The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials:

1. axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk, 2. 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining, 3. pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands, 4. derotation between the pelvis and shoulders with uneven straps, and 5. an active mechanism with sensors added to the brace to maintain correct posture.

Вмешательства

• Устройство Anisotropic Textile Braces
  The period of the wear trial is 12-18 months in time for each subject. Wear instructions (23 hrs per day) and wash instructions will be provided to the subjects before the wear trial. Evaluation tests based on health in consideration of the use of the anisotropic textile brace (heart and pulmonary function testing and sensory level measurements) will be carried out at the beginning of the wear trial. Clinical, radiography, self-report and follow-up after completion of the study

Первичные конечные точки

• Progression of the spinal curve [Срок оценки: 18 months]

Вторичные конечные точки (1)

• Posture improvement [Срок оценки: 18 months]

Критерии участия

Критерии включения

• Aged 10 to 14 years
• Diagnosis of AIS
• a Cobb's angle between 20 to 30 degrees
• a Risser grade of the iliac crest of ≤ 2
• 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

• Contraindications for x-ray exposure
• 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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The Hong Kong Polytechnic University — Гонконг
• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT02589106 · GRF2016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗