RecruitingNot ApplicableNCT04116723

Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis


Sponsor

The Hong Kong Polytechnic University

Enrollment

100 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 10 YearsMax Age: 15 Years

Inclusion Criteria5

  • 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

Exclusion Criteria7

  • 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

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Interventions

DEVICEFlexible 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.


Locations(1)

The Hong Kong Polytechnic University

Hong Kong, China

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NCT04116723


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