Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
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|ClinicalTrials.gov Identifier: NCT03716843|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment|
|Adolescent Idiopathic Scoliosis||Other: Pressure monitoring system|
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Pressure monitoring system for AIS
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.
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 pressure measurement system will be used to obtain an accurate and adequate comparison of the forces applied to the patients. The effectiveness of the anisotropic textile brace will be evaluated through X-ray radiography, and its correction effect with be compared with that of the TLSO brace.
Other Name: Pressure measurement undergarment
- Investigate on brace Cobb's angle [ Time Frame: 2 hours after wearing the brace ]Measure lateral curve of vertebra on spine x-ray AP view. The effectiveness of the modified or anisotropic textile brace will be evaluated through X-ray radiography, and its correction effect will be compared with that of the TLSO brace.
- Overall pressure distribution [ Time Frame: 2 minutes after wearing the brace ]The pressure measurement system will be used to obtain an accurate and adequate comparison of the forces (kPa) applied by TLSO brace and modified brace.
- Visual analogue scale [ Time Frame: 6 month ]A visual analogue scale (VAS) for pain due to the brace, a VAS for motivation and a VAS for quality of life graded 0 to 100 mm will also be used. For pain, 0 represents the absence of pain as a motivation, and 0 represents the absence of discomfort in daily life. Statistical analysis will be performed to determine the relationship between the level of brace correction force and effect. After this relationship is established, patients will no longer suffer unnecessary strain and pain caused by the brace. Optimum correction force will be achieved with higher patient comfort, reducing the possibility of developing pressure ulcers and improving user compliance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716843
|Contact: Joanne Yip, PhDemail@example.com|
|Contact: Kit Yick, PhDfirstname.lastname@example.org|
|The Hong Kong Polytechnic University|
|Tsim Sha Tsui, Kolwoon, Hong Kong, 00852|
|Principal Investigator:||Joanne Yip, PhD||The Hong Kong Polytechnic University|