Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis

NCT04116723 | Recruiting DMC

• 1 other identifier: GRF2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scoliosis

Keywords

Flexible brace

Outcome Measures

Primary Outcomes (1)

• In-flexible brace Cobb angle measurements

  1\. Number of Participants Maintaining Cobb Angle Stability (\<5° Increase) After Wearing the Brace for 2 Hours, as Measured by Spine X-ray (AP View).

  2 hours after wearing the brace

Secondary Outcomes (2)

• Idea pressure level measurements

  2 hours after wearing the brace

• Visual analogue scale (VAS) Scores

  2 hours after wearing the brace

Study Arms (1)

Flexible brace

EXPERIMENTAL

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.

Device: Flexible brace

Interventions

Flexible brace DEVICE

Participants will be invited to undergo a fitting session of a flexible brace. After the fitting session, participants will join a two-hours wear trial of the flexible brace. Participants are required to wear the brace for two-hours and undergo assessments before and after the wear trial. The measurement outcomes of the assessment include 1) X-ray scan, 2) 3D body scan, 3) garment pressure, and 4) questionnaire.

Flexible brace

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Contraindications for x-ray exposure
• Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
• History of previous surgical treatment for AIS
• Contraindications for pulmonary and/ or exercise tests
• Psychiatric disorders
• Recent trauma
• Recent traumatic (emotional) event

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CN (1)