Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Scoliosis is the three-dimensional (3D) deformity of the spine and trunk. The majority or 80% of the scoliosis cases are idiopathic which means that the cause is unknown. The progression of scoliosis is much more frequently seen in females and severely scoliotic patients face a higher risk of different health problems in their adult life Bracing is the most commonly used non-invasive treatment for patients with smaller spinal curves which are usually between 21 and 40 degrees at Risser stage 0, 1 or 2. However, scoliosis braces are traditionally constructed based on the experience of orthotists. Since 3D spinal deformities are complex, the design and evaluation of braces are challenging with no consensus on an optimal brace design. AI and ML methods therefore constitute a new approach to address the difficulties in designing braces.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 10
Maximum Age: 15
Healthy Volunteers: f
View:

• Teenagers diagnosed with adolescent idiopathic scoliosis

• Cobb's angle between 20 to 45 degrees

• Immature skeletons (Risser grade 0-2)

• Types of scoliosis are classified by the Lenke classification system

• Have received rigid brace treatment

Locations
Other Locations
China
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Flexible brace
The design of the flexible brace incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) artificial hinge bone for the strategical application and fixation of corrective panel, 3) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov