Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Scoliosis Clinical Trial

Official title: Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Scoliosis

• NCT number: NCT02589106
• Study type: Interventional
• Source: The Hong Kong Polytechnic University
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 2017
• Completion date: December 31, 2025