Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 10
Maximum Age: 14
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Joanne Yip, PhD
tcjyip@polyu.edu.hk
852-27664848
Backup
Kit-Lun Yick, PhD
kit-lun.yick@polyu.edu.hk
852-27666551
Time Frame
Start Date: 2017-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Anisotropic Textile Braces
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.
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov