Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

ConditionScoliosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age10-14
SponsorThe Hong Kong Polytechnic University

About this trial

One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological concerns into consideration.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 10 to 14 years

Diagnosis of AIS

a Cobb's angle between 20 to 30 degrees

a Risser grade of the iliac crest of ≤ 2

Disqualifiers

Contraindications for x-ray exposure

Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature

History of previous surgical or orthotic treatment for AIS

Contraindications for pulmonary and/ or exercise tests

Trial design

Design model

Single group

Treatments tested in this trial

  • Anisotropic Textile Braces

    Device

    The period of the wear trial is 12-18 months in time for each subject. Wear instructions (23 hrs per day) and wash instructions will be provided to the subjects before the wear trial. Evaluation tests based on health in consideration of the use of the anisotropic textile brace (heart and pulmonary function testing and sensory level measurements) will be carried out at the beginning of the wear trial. Clinical, radiography, self-report and follow-up after completion of the study

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Anisotropic Textile BracesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression of the spinal curve

The spinal curve is said to be under control if the increase in the Cobb's angle is \<5°

Time frame
18 months

Secondary outcomes

1

Posture improvement

Improvement of posture by clinical photographs assessment

Time frame
18 months

Other outcomes

Sponsors and contacts

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