About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Anisotropic Textile Braces
DeviceThe 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
Treatment groups
Trial outcomes
Primary outcomes
Progression of the spinal curve
The spinal curve is said to be under control if the increase in the Cobb's angle is \<5°
Secondary outcomes
Posture improvement
Improvement of posture by clinical photographs assessment
Sponsors and contacts
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