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RECRUITING
NCT02589106
NA

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

10 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2017-01

Completion Date

2025-12-31

Last Updated

2025-03-13

Healthy Volunteers

No

Conditions

Interventions

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

Locations (2)

The Hong Kong Polytechnic University

Hong Kong, Guangdong, China

The Hong Kong Polytechnic University

Hong Kong, China