Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Scoliosis

Treatments: Device: Anisotropic Textile Braces

Study type: Interventional

Funder types: Other

Identifiers

NCT02589106

GRF2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Anisotropic Textile Braces

Experimental group

Description:

The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials: a) axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk, b) 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining, c) pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands, d) derotation between the pelvis and shoulders with uneven straps, and e) an active mechanism with sensors added to the brace to maintain correct posture.

Treatment:

Device: Anisotropic Textile Braces