Adolescent Idiopathic ScoliosisNCT05790031
Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
A study testing Intelligent Nighttime Brace in people with Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Read more about this study
- Who is it for?
- Ages 10 to 13 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Intelligent Nighttime Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2028
- Phase
- Interventional
- 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 13 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- between the ages of 10-13,
- scoliosis with a Cobb angle larger between 10 -25 degrees;
- No prior treatment
- Pre-menarche or post- menarche by no more than 1 year
- Ability to read and understand English or Chinese
- Physical and mental ability to adhere to intelligent nighttime braces protocol
Who cannot join
- History of previous surgical or orthotic treatment for AIS
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- Contraindications for pulmonary and/ or exercise tests
- Psychiatric disorders
- Recent trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Joanne Yip, phd
About this study
Official title: Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.
Read the detailed description
The design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as
- compression and pulling forces through a customizable rigid brace
- lumbar flexion by using a supporting air-belt.
- three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction
- adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Intelligent Nighttime Brace
- Keywords
- Scoliosis, Bracing Treatment
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Nighttime BraceDevice
Participants will be invited to undergo a fitting session of intelligent nighttime brace. After the fitting, participants will join a 6-month wear trial of the intelligent nighttime brace. Participants are required to wear the intelligent nighttime brace for 8 hours a day during sleeping and compliance will be recorded by an intelligent monitoring system. Participants will be invited to undergo assessments before the wear trial, after the trials of 3 months and after the trial of 6 months. The measure outcomes of the assessment include 1)ultrasound scanning image, 2)3D body scanning, 3)garment pressure, 4) questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Intelligent Nighttime Brace | Experimental | The design of intelligent nighttime brace will incorporate different mechanism, such as a) compression and pulling forces through a customisable rigid brace, b) lumbar flexion by using a supporting air-belt, c) three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction, d) adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users Receives: Device: Intelligent Nighttime Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the in-brace Cobb angle
- Number of Participants Maintaining Cobb Angle Stability (<5° Increase) After Wearing the Brace for 2 Hours, as Measured by Spine X-ray (AP View).
Measured: 2 hours and 6 months after wearing the brace
Secondary outcomes (3)
Contour control
Use a 3D body scanner to measure the contour asymmetry. By using 3D scanning images, the contour asymmetry changes over a six-month period will be assessed.
Measured: 6 months
Force measurements and monitoring
Measure the brace interface pressure by the Novel Pliance-xf-16 analyser. The bio-mechanics of the intelligent nighttime brace are assessed by the changes of the pressure distribution. A real-time intelligent system is use to monitor the pressure distribution.
Measured: 6 months
Health-related quality of life (SRS-22)
Measure the quality of life by validated questionnaire, Euroqol (EQ-5D-5L). The five dimensions of the descriptive system are mobility, self-care, regular activities, pain/comfort, and anxiety/depression. The patients with higher values represent a worse outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05790031
- Sponsor's protocol ID
- ITS/007/22
- Status last verified
- Oct 2024
- First submitted
- 16 Mar 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05790031
- Acronym / sponsor ID
- ITS/007/22
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Bracing Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Mar 2023 (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) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.
Detailed description
The design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as
- compression and pulling forces through a customizable rigid brace
- lumbar flexion by using a supporting air-belt.
- three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction
- adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intelligent Nighttime Brace | Experimental | Device: Intelligent Nighttime BraceThe design of intelligent nighttime brace will incorporate different mechanism, such as a) compression and pulling forces through a customisable rigid brace, b) lumbar flexion by using a supporting air-belt, c) three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction, d) adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- between the ages of 10-13,
- scoliosis with a Cobb angle larger between 10 -25 degrees;
- No prior treatment
- Pre-menarche or post- menarche by no more than 1 year
- Ability to read and understand English or Chinese
Key exclusion criteria (5 listed)
- History of previous surgical or orthotic treatment for AIS
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- Contraindications for pulmonary and/ or exercise tests
- Psychiatric disorders
- Recent trauma
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 |
|---|---|---|
| Intelligent Nighttime BraceParticipants will be invited to undergo a fitting session of intelligent nighttime brace. After the fitting, participants will join a 6-month wear trial of the intelligent nighttime brace. Participants are required to wear the intelligent nighttime brace for 8 hours a day during sleeping and compliance will be recorded by an intelligent monitoring system. Participants will be invited to undergo assessments before the wear trial, after the trials of 3 months and after the trial of 6 months. The measure outcomes of the assessment include 1)ultrasound scanning image, 2)3D body scanning, 3)garment pressure, 4) questionnaires | Device | Intelligent Nighttime Brace |
Primary outcome
Investigate the in-brace Cobb angle
Time frame: 2 hours and 6 months after wearing the brace
1. Number of Participants Maintaining Cobb Angle Stability (<5° Increase) After Wearing the Brace for 2 Hours, as Measured by Spine X-ray (AP View).
3 secondary outcomes
Contour control
Time frame: 6 months
Force measurements and monitoring
Time frame: 6 months
Health-related quality of life (SRS-22)
Time frame: 6 months
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 15 Oct 2024.
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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?
A study testing Intelligent Nighttime Brace in people with Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in China.
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 6 inclusion and 5 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 15 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 China. 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 (852-27665111 ext. 4848, 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?
Investigate the in-brace Cobb angle (time frame: 2 hours and 6 months 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 15 Oct 2024.