Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716843
• Other study ID #: GRF2019
• Status: Recruiting
• Start date: January 2, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: Joanne Yip, PhD
• Phone: 852-27664848
• Email: joanne.yip[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Tsim Sha Tsui	Kolwoon

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The University of Hong Kong, Washington University School of Medicine

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate on brace Cobb's angle	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.	2 hours after wearing the brace
Secondary	Overall pressure distribution	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.	2 minutes after wearing the brace
Secondary	Visual analogue scale	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.	6 month