Adolescent Idiopathic Scoliosis Clinical Trial
Official title:
Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Verified date | September 2023 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 10 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 10 Years to 13 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Cobb angle measurements of intelligent nighttime brace | Measure lateral curvature of vertebra on spine x-ray AP view (unit: degree) will be measured by using EOSĀ® low does x-ray. | 2 hours after wearing the brace and 6 months | |
Secondary | Contour control | Use a 3D body scanner to measure the contour asymmetry. By using 3D scanning images, the contour asymmetry changes over a six-month period will be assessed. | 6 months | |
Secondary | Force measurements and monitoring | Measure the brace interface pressure by the Novel Pliance-xf-16 analyser. The bio-mechanics of the intelligent nighttime brace are assessed by the changes of the pressure distribution. A real-time intelligent system is use to monitor the pressure distribution. | 6 months | |
Secondary | Health-related quality of life (SRS-22) | Measure the quality of life by validated questionnaire, Euroqol (EQ-5D-5L). The five dimensions of the descriptive system are mobility, self-care, regular activities, pain/comfort, and anxiety/depression. The patients with higher values represent a worse outcome. | 6 months |
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