NCT02589106

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Scoliosis

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2017-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2015-10-28
• Last updated: 2025-03-13

Locations

2 sites across 1 country: China