Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

NCT ID: NCT02589106

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Anisotropic Textile Braces

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Joanne Yip

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, Guangdong, China

Site Status: RECRUITING

The Hong Kong Polytechnic University

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Joanne Yip, PhD

Role: CONTACT

tcjyip@polyu.edu.hk

852-27664848

Kit-Lun Yick, PhD

Role: CONTACT

kit-lun.yick@polyu.edu.hk

852-27666551

Facility Contacts

Joanne Yip, PhD

Role: primary

tcjyip@polyu.edu.hk

852-27664848

Kit-Lun Yick, PhD

Role: backup

kit-lun.yick@polyu.edu.hk

852-27666551

Other Identifiers

GRF2016

Identifier Type: -

Identifier Source: org_study_id