Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age10-13
SponsorThe Hong Kong Polytechnic University

About this trial

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

between the ages of 10-13,

scoliosis with a Cobb angle larger between 10 -25 degrees;

No prior treatment

Pre-menarche or post- menarche by no more than 1 year

Disqualifiers

History of previous surgical or orthotic treatment for AIS

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

Contraindications for pulmonary and/ or exercise tests

Psychiatric disorders

Trial design

Design model

Single group

Treatments tested in this trial

  • Intelligent Nighttime Brace

    Device

    Participants will be invited to undergo a fitting session of intelligent nighttime brace. After the fitting, participants will join a 6-month wear trial of the intelligent nighttime brace. Participants are required to wear the intelligent nighttime brace for 8 hours a day during sleeping and compliance will be recorded by an intelligent monitoring system. Participants will be invited to undergo assessments before the wear trial, after the trials of 3 months and after the trial of 6 months. The measure outcomes of the assessment include 1)ultrasound scanning image, 2)3D body scanning, 3)garment pressure, 4) questionnaires

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Intelligent Nighttime BraceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Investigate the in-brace Cobb angle

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).

Time frame
2 hours and 6 months after wearing the brace

Secondary outcomes

1

Contour control

Use a 3D body scanner to measure the contour asymmetry. By using 3D scanning images, the contour asymmetry changes over a six-month period will be assessed.

Time frame
6 months
2

Force measurements and monitoring

Measure the brace interface pressure by the Novel Pliance-xf-16 analyser. The bio-mechanics of the intelligent nighttime brace are assessed by the changes of the pressure distribution. A real-time intelligent system is use to monitor the pressure distribution.

Time frame
6 months
3

Health-related quality of life (SRS-22)

Measure the quality of life by validated questionnaire, Euroqol (EQ-5D-5L). The five dimensions of the descriptive system are mobility, self-care, regular activities, pain/comfort, and anxiety/depression. The patients with higher values represent a worse outcome.

Time frame
6 months

Other outcomes

Sponsors and contacts

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