Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intelligent Nighttime Brace.
- Who it may be relevant to
- Registry conditions: Adolescent Idiopathic Scoliosis. Basic parameters: 10 years — 13 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Overview
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.
Detailed description
The design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as
1. compression and pulling forces through a customizable rigid brace 2. lumbar flexion by using a supporting air-belt. 3. three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction 4. adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users
Interventions
- Device Intelligent Nighttime Brace
Participants will be invited to undergo a fitting session of intelligent nighttime brace. After the fitting, participants will join a 6-month wear trial of the intelligent nighttime brace. Participants are required to wear the intelligent nighttime brace for 8 hours a day during sleeping and compliance will be recorded by an intelligent monitoring system. Participants will be invited to undergo assessments before the wear trial, after the trials of 3 months and after the trial of 6 months. The m
Primary outcome measures
- Investigate the in-brace Cobb angle [Time frame: 2 hours and 6 months after wearing the brace]
Secondary outcome measures (3)
- Contour control [Time frame: 6 months]
- Force measurements and monitoring [Time frame: 6 months]
- Health-related quality of life (SRS-22) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- between the ages of 10-13,
- scoliosis with a Cobb angle larger between 10 -25 degrees;
- No prior treatment
- 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 intelligent nighttime braces protocol
Exclusion criteria
- History of previous surgical or orthotic treatment for AIS
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- Contraindications for pulmonary and/ or exercise tests
- Psychiatric disorders
- Recent trauma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT05790031 · ITS/007/22