Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis
• Intervention / Treatment: Device: Anisotropic Textile Braces

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanne Yip, PhD; Phone Number: 852-27664848; Email: tcjyip@polyu.edu.hk
• Study Contact Backup: Name: Kit-Lun Yick, PhD; Phone Number: 852-27666551; Email: kit-lun.yick@polyu.edu.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Joanne Yip, PhD; Phone Number: 852-27664848; Email: tcjyip@polyu.edu.hk
    • Contact: Kit-Lun Yick, PhD; Phone Number: 852-27666551; Email: kit-lun.yick@polyu.edu.hk
  • Guangdong
    • Hong Kong, Guangdong, China, 999077
      • Recruiting
      • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of the spinal curve	The spinal curve is said to be under control if the increase in the Cobb's angle is <5°	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posture improvement	Improvement of posture by clinical photographs assessment	18 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimated): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Anisotropic Textile Braces
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: GRF2016