NCT05790031 Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
| NCT ID | NCT05790031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2027-12-31 |
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 10 participants in total. It began in 2023-09-01 with a primary completion date of 2027-12-31.
⚠ 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
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.
Eligibility Criteria
Inclusion Criteria: 1. between the ages of 10-13, 2. scoliosis with a Cobb angle larger between 10 -25 degrees; 3. No prior treatment 4. Pre-menarche or post- menarche by no more than 1 year 5. Ability to read and understand English or Chinese 6. Physical and mental ability to adhere to intelligent nighttime braces protocol Exclusion Criteria: 1. History of previous surgical or orthotic treatment for AIS 2. Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature 3. Contraindications for pulmonary and/ or exercise tests 4. Psychiatric disorders 5. Recent trauma
Contact & Investigator
Joanne Yip, phd
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT05790031 clinical trial?
This trial is open to female participants only, aged 10 Years or older, up to 13 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05790031 currently recruiting?
Yes, NCT05790031 is actively recruiting participants. Contact the research team at joanne.yip@polyu.edu.hk for enrollment information.
Where is the NCT05790031 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT05790031 clinical trial?
NCT05790031 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Joanne Yip, phd at The Hong Kong Polytechnic University. The trial plans to enroll 10 participants.