Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Scoliosis Clinical Trial

Official title:

Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02589106
• Other study ID #: GRF2016
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

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

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Posture improvement	Improvement of posture by clinical photographs assessment	18 months