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Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis

NCT04116723 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-18

No results posted yet for this study

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

Interventions

DEVICE

Flexible brace

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.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116723 on ClinicalTrials.gov