NCT02589106 Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
| NCT ID | NCT02589106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2017-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2017-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02589106 clinical trial?
This trial is open to female participants only, aged 10 Years or older, up to 14 Years, studying Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02589106 currently recruiting?
Yes, NCT02589106 is actively recruiting participants. Contact the research team at tcjyip@polyu.edu.hk for enrollment information.
Where is the NCT02589106 trial being conducted?
This trial is being conducted at Hong Kong, China, Hong Kong, China.
Who is sponsoring the NCT02589106 clinical trial?
NCT02589106 is sponsored by The Hong Kong Polytechnic University. The trial plans to enroll 15 participants.