Adolescent Idiopathic ScoliosisNCT03716843
Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
An observational study of Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Pressure monitoring system
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jan 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The study will be divided into two phases. In Phase 1, an exploratory pilot study will be performed with up to two different braces tried on the same patient in one spinal centre in Hong Kong.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Tsim Sha Tsui, Kolwoon, 00852
Joanne Yip, PhD, 85227664848, joanne.yip@polyu.edu.hk
Kit Yick, PhD, 85227666551, tcyick@polyu.edu.hk
About this study
Official title: Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Pressure monitoring system
- Keywords
- Dynamic Pressure Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure monitoring systemOther
Also called Pressure measurement undergarment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pressure monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall pressure distribution and dynamic pressure
- Dynamic Pressure Changes (kPa) Monitored Over 2 Hours of Brace Wear, as Measured by the Optical Fibre Sensors.
- Overall Pressure Distribution (kPa) Monitored Over 2 Hours of Brace, as Measured by the Optical Fibre Sensors.
Measured: 2 hours after wearing the brace
Secondary outcomes (2)
Scoliosis Research Society Quality of Life Questionnaire
- 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.
Measured: 6 months after wearing the brace
Visual analogue scale
- 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.
Measured: 6 months after wearing the brace
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start2 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Yip, The Hong Kong Polytechnic University
- Investigators
- Joanne Yip, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716843
- Sponsor's protocol ID
- GRF2019
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2018
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
- ClinicalTrials.gov ID
- NCT03716843
- Acronym / sponsor ID
- GRF2019
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Dynamic Pressure Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, The University of Hong Kong
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure monitoring system for AIS | – | Other: Pressure monitoring systemAdolescent 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will be divided into two phases. In Phase 1, an exploratory pilot study will be performed with up to two different braces tried on the same patient in one spinal centre in Hong Kong.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure monitoring systemAlso: Pressure measurement undergarmentThe 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 | Pressure monitoring system for AIS |
Primary outcome
Overall pressure distribution and dynamic pressure
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanne Yip, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne Yip, PhD (852-27664848, joanne.yip@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall pressure distribution and dynamic pressure (time frame: 2 hours after wearing the brace). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.