Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pressure monitoring system.
- Who it may be relevant to
- Registry conditions: Adolescent Idiopathic Scoliosis. Basic parameters: 10 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
Overview
Adolescent idiopathic scoliosis (AIS) involves three-dimensional spinal deformity in children aged between 10 and 16. Traditional braces modify the natural dynamics and thus the mechanical behaviour of the scoliotic spine through external constraints. Patients usually develop pressure ulcers and skin irritation when prescribed brace treatment for 18-23 hours per day. The excessive pressure, unknown pressure distribution and pressure shifting between the human body and the brace causes the effects of brace treatment to be unpredictable. Dynamic pressure monitoring system will be developed based on the body landmarks of scoliotic patients and critical areas where active pressure is applied by the brace. The overall pressure distribution and dynamic pressure between the body and the thoraco-lumbo-sacral orthosis (TLSO) rigid brace will be measured. The efficacy of the brace design will be evaluated, and the maximum compressive stresses that patients can endure on different body parts without pressure injury can be computed.
Detailed description
Global rates of adolescent idiopathic scoliosis (AIS) range from 0.9% to 12%, and within this population, approximately 10% of adolescents aged 10-16 will eventually need treatment. The most common conservative treatment is bracing, in which AIS patients are prescribed a brace for 18 to 23 hours daily until skeletally mature. The objective of bracing is to stop curve progression and restore normal alignment of the spine by active pressure from the brace. There is strong clinical evidence of a positive correlation between the tightness of daily brace application and the ability of the brace to decrease the risk of curve progression to a surgical threshold. However, patients suffer physical and functional discomfort resulting from pressure points, including pressure ulcers, skin irritation and even asthma attacks, which reduces compliance with brace treatment. Clearly, the knowledge of human body responses to pressure applied by brace treatment remains lacking.
This multi-disciplinary collaborative study involves experts in electrical and electronic engineering, orthopaedics, materials science and textiles, and biomechanics. A revolutionary pressure measurement system that integrates fibre optic sensors with textile yarns will be developed in the form of an undergarment. The sensor arrangement in the undergarment will be designed according to the body landmarks of scoliotic patients and critical areas where active pressure is applied by the brace. The overall pressure distribution and dynamic pressure between the body and the scoliosis brace will be measured. The efficacy of the brace design will be evaluated, and the maximum compressive stresses that patients can endure on different body parts without pressure injury can be computed.
Academia, clinicians and AIS patients are predicted to benefit from using the pressure system, which determines the optimum pressure to be exerted on patients while minimizing pressure injuries. The output of the project can be extended to the standardization of pressure levels applied by different orthotic devices and will add a new dimension to fibre optic applications in biomechanics.
Interventions
- Other Pressure monitoring system
The pressure measurement undergarment will be given to all consenting AIS patients who have received their own thoraco-lumbo-sacral orthosis (TLSO) rigid brace. Each patient will wear the undergarment first and the TLSO brace on top. FBG sensors embedded in the undergarment will measure each pressure signal at approximately 2 minutes. The average force reading will be calculated. Then, the experiment will be repeated once, but the anisotropic textile brace will replace the TLSO brace. The press
Primary outcome measures
- Overall pressure distribution and dynamic pressure [Time frame: 2 hours after wearing the brace]
Secondary outcome measures (2)
- Scoliosis Research Society Quality of Life Questionnaire [Time frame: 6 months after wearing the brace]
- Visual analogue scale [Time frame: 6 months after wearing the brace]
Eligibility criteria
Inclusion criteria
- Teenagers diagnosed with adolescent idiopathic scoliosis
- Cobb's angle between 25 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Tsim Sha Tsui
Identifiers
NCT: NCT03716843 · GRF2019