Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

NCT02589106 | Recruiting DMC

• 1 other identifier: GRF2016
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Scoliosis

Keywords

Anisotropic Textile Braces

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Posture improvement

  18 months

Study Arms (1)

Anisotropic Textile Braces

EXPERIMENTAL

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

Interventions

Anisotropic Textile Braces 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

Anisotropic Textile Braces

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, Guangdong, 999077, China

RECRUITING

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Joanne Yip, PhD

CONTACT

852-27664848; tcjyip@polyu.edu.hk

Kit-Lun Yick, PhD

CONTACT

852-27666551; kit-lun.yick@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: January 1, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (2)