Overview

This trial is active, not recruiting.

Condition scoliosis
Treatment anisotropic textile braces
Phase phase 0
Sponsor The Hong Kong Polytechnic University
Start date January 2017
End date December 2019
Trial size 15 participants
Trial identifier NCT02589106, GRF2016

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
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

Primary Outcomes

Measure
Progression of the spinal curve
time frame: 18 months

Secondary Outcomes

Measure
Posture improvement
time frame: 18 months

Eligibility Criteria

Female participants from 10 years up to 14 years old.

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

Additional Information

Official title Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by The Hong Kong Polytechnic University.