Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
- Conditions
- Adolescent Idiopathic Scoliosis
- Interventions
- Other: Pressure monitoring system
- Registration Number
- NCT03716843
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pressure monitoring system for AIS Pressure monitoring system Adolescent idiopathic scoliosis (AIS) patients (1) all target subjects are aged 10 to 15 years old with immature skeletons (Risser grade 0-2); (2) they are diagnosed with AIS with a Cobb angle between 25-45° and high risk for curve progression; (3) the types of scoliosis are classified by the Lenke classification system; and (4) the subjects have received rigid brace treatment.
- Primary Outcome Measures
Name Time Method Overall pressure distribution and dynamic pressure 2 hours after wearing the brace 1. Dynamic Pressure Changes (kPa) Monitored Over 2 Hours of Brace Wear, as Measured by the Optical Fibre Sensors.
2. Overall Pressure Distribution (kPa) Monitored Over 2 Hours of Brace, as Measured by the Optical Fibre Sensors.
- Secondary Outcome Measures
Name Time Method Scoliosis Research Society Quality of Life Questionnaire 6 months after wearing the brace 1. Change in Scoliosis Research Society Score (SRS-22r) for Quality of Life Before and After Brace Usage. It includes five domains that evaluate function, pain, self-image, psychosocial status and satisfaction with the treatment and will be distributed to both experimental and control groups at 0 and 6 months. It has a minimum score of 22 and a maximum score of 110, with higher scores representing greater patient quality of life.
Visual analogue scale 6 months after wearing the brace 1. Change in Visual Analogue Scale (VAS) Scores for Pain Before and After Brace Usage.
VAS is a straight horizontal line measuring 100 mm. The ends are defined as the extreme limits of pain, oriented from the left at 0 mm to the right at 100 mm. Typically, higher scores indicate a worse outcome, i.e., more pain.
Trial Locations
- Locations (1)
The Hong Kong Polytechnic University
🇭🇰Tsim Sha Tsui, Kolwoon, Hong Kong