Clinical trial NCT05790031: Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Official title: Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis, Bracing Treatment
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Investigate the in-brace Cobb angle
timeFrame: 2 hours and 6 months after wearing the brace
Secondary outcomes:
measure: Contour control
timeFrame: 6 months
measure: Force measurements and monitoring
timeFrame: 6 months
measure: Health-related quality of life (SRS-22)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Joanne Yip, phd
role: PRINCIPAL_INVESTIGATOR
References: