Adolescent Idiopathic ScoliosisNCT03929042
Evaluating the Effectiveness of Posture Correction Girdle for Adolescents With Early Scoliosis
A study testing Posture correction girdle in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Through the ITF-Tier 3 project (ITS/ 237/ 11), a prototype of the posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses has been developed for preteen and teenage girls aged 10 to 13 who have the early stages of scoliosis. 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?
- Posture correction girdle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Jul 2017to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- • Satisfy SRS criteria for bracing15
- Curretly treated for rigid underarm brace
- Primary Cobb angle between 25 to 40 degrees
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 or orthotic 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.
Hong Kong1 site, 1 recruiting
- Recruiting
Duchess of Kent Children's Hospital
Hong Kong
Dr Kenny Kwan, BMBCh (Oxon), +852 22554654, kyhkwan@hku.hk
Ms Amy Cheung, MA, +852 22554654, amycheung114@ortho.hku.hk
About this study
Through the ITF-Tier 3 project (ITS/ 237/ 11), a prototype of the posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses has been developed for preteen and teenage girls aged 10 to 13 who have the early stages of scoliosis. The girdle provides a corrective force onto the torso by the warping and elastic extension of the shoulder straps and waistband and the insertion of semi-rigid EVA padding and uses a point-pressure support system to achieve the target of posture improvement and spinal progression control with physical and psychological comfort.
In order to evaluate the effectiveness of the posture correction girdle, it is proposed to recruit 10 patients to take low dose x-ray (sterEOS) at QMH at supine position. Then, the patient should wear the girdle for two hours and take another x-ray at standing position. If the Cobb's angle of the patient on girdle at standing position can be same as her supine position. It can prove the effectiveness of the girdle.
Read the detailed description
Background Information Scoliosis in patients between 10 and 18 years of age is termed adolescent scoliosis. The most common type of scoliosis is one of which the cause is not known. This is called "idiopathic" or "adolescent idiopathic scoliosis (AIS)". The main risk factors of curve progression could be skeletal immaturity, female gender and large curve magnitude. It has been found that nearly 10% of all adolescents have some degree of spinal curve or deformity after their tenth year. The health of patients, such as cardiac and pulmonary functions, may be affected if their spinal deformity is very serious. Hence, the most ideal way is to monitor and control spinal curvature once AIS has been found.
Treatment options for scoliosis In general, patients are suggested to undergo different types of treatments according to their spine situations and stage of scoliosis. Surgery is suggested for patients with spinal curves that are greater than 41-50 degrees, while bracing is a non-invasive treatment suggested for those with spinal curves between 21-40 degrees. Thoraco-lumber-sacral-orthosis (TLSO) or cervico-thoraco-lumbo-sacral orthosis (CTLSO) braces are the most commonly prescribed and used braces. The 3-point pressure system is primarily applied by all TLSO braces in order to correct the spinal curve and reduce the curve progression. The plaster cast is tailor-made according to the body shape of each patient. The upper torso of the wearer needs to be tightly compressed by this non-breathable material for 23 hours every day. The duration of the treatment duration will be for years until the bones are fully mature.
Aside from the fact that newer types of flexible brace products in the market are not available in large numbers, their effectiveness continues to be controversial and there is much room for improvement. The SpineCor Dynamic brace is one of the flexible braces used to treat AIS. The theory behind the SpineCor system is known as spinal coupling. Spinal coupling corrects deformities by reversing abnormal posture and body shape into their opposite position so that the abnormal alignment of the spine can be corrected. As the spinal curve of each patient is different, thus appropriate positions and tensions of the elastics will be respectively placed and adjusted by a professional before the patient wears the brace. It has been found that the curve progression rate of those who wear the SpineCor Dynamic brace is significantly higher than those who wear the rigid brace. It is believed that the ineffectiveness of the flexible brace may be caused by the shifting of the elastic bands. The elastic bands present on the brace are not fixed to the body of the wearer, and may easily shift to other areas during movement. Hence, the corrective force will no longer be exerted onto the correct position for posture and body shape correction.
A summary of the research rationale is listed below. Research rationale 1: Low treatment compliance Treatment through the use of a hard brace has low compliance due to discomfort and psychological issues, such as an awkward and bulky appearance. Flexible braces have other issues, such as discomfort caused by the elastic bands, inconvenience when going to the toilet, and unusual designs, which also result in low compliance. New designs that aim to improve compliance are therefore extremely important.
Research rationale 2: Limited product choice for adolescents with early scoliosis Hard brace treatment is overly excessive for adolescents with early scoliosis due to the high corrective force which nearly constrains all movements. The flexible brace treatment is an alternative option; however, its efficacy remains controversial. Intimate apparel that has a specialized design for teenagers with scoliosis is limited and a large majority can only provide some improvement for poor postures, such as hunchback. A scientific approach should be used to design and develop functional intimate apparel as a treatment option for adolescents with early scoliosis.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Posture correction girdle
- Keywords
- AIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture correction girdleDevice
Our research team has designed a prototype of posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses as an alternative to hard brace for AIS. The design of the posture correction girdle incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.
| Study group | Role | What they receive |
|---|---|---|
| Posture Correction Girdle | Experimental | Our research team has designed a prototype of posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses as an alternative to hard brace for AIS. The design of the posture correction girdle incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system. Receives: Device: Posture correction girdle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the spinal correction of posture correction girdle and hard brace
The Cobb angle (unit: degree) of posture correction girdle and hard brace will be compared and reported.
Measured: 2 weeks
Secondary outcomes (6)
Measure the pressure forces exerted by posture correction girdle and hard brace
The pressure forces (unit: kpa) of posture correction girdle and hard brace will be compared and reported.
Measured: 2 weeks
Measure the spinal correction of posture correction girdle after 6 months
The Cobb angle (unit: degree) after 6-month of posture correction girdle treatment will be calculated and reported.
Measured: 6 months
Measure the pressure changes of posture correction girdle after 6 months
The pressure forces (unit: kpa) after 6-month of posture correction girdle treatment will be calculated and reported.
Measured: 6 months
Measurement of patient-related outcome of posture correction girdle and hard brace by EQ-5D-5L
Health-related quality of life, Euroqol (EQ-5D-5L)
The descriptive system comprises 5 dimensions in 5 questions. Each dimension has 5 levels which ranges from 0-no problems to 4-extreme problems. Total score is ranged from 0 to 20. The higher values represent a worse outcome.
Measured: 6 months
Measurement of patient-related outcome of posture correction girdle and hard brace by SRS-22
Health-related quality of life (SRS-22)
The questionnaire consists of 22 questions and each question has 5 levels. The maximum score in each domain is 5 (greatest quality) and minimum score is 1 (poorest quality). Total score is ranged from 22 to 110. The higher values represent a better outcome.
Measured: 6 months
Measurement of patient-related outcome of posture correction girdle and hard brace by TAPS
Patients' perception of self-image (TAPS)
The TAPS included 3 sets of figures that depict the trunk from 3 viewpoints. Drawings are scored from 1 (greatest deformity) to 5 (smallest deformity). A mean score ranged from 1 to 5 is obtained. The higher mean scores represent a better 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 posted26 Apr 2019
- Study start17 Jul 2017
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (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 University of Hong KongThe 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
- Model description
- Patients currently on underarm brace treatment will be eligible for participation in our study. For those that agree to participate, a AP/lat standing X-ray and force measurements of the brace on the rib and loin hump will be taken. They will be then be asked to wear a customised postural correction girdle 24 hours after they have taken off the brace. The same study assessments will be conducted. Patients whose forces and radiological Cobb correction are comparable between the two methods of treatment will be given a choice to either continue the hard brace or wear the posture correction girdle.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Dr. Kenny Kwan, The University of Hong Kong
- Investigators
- Prof Kenneth Cheung, MBBS (UK), MD (HK), Study chair, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929042
- Sponsor's protocol ID
- UW16-505
- Status last verified
- Nov 2021
- First submitted
- 18 Jul 2017
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Posture Correction Girdle for Adolescents With Early Scoliosis
- ClinicalTrials.gov ID
- NCT03929042
- Acronym / sponsor ID
- UW16-505
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- AIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Apr 2019 (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.
Through the ITF-Tier 3 project (ITS/ 237/ 11), a prototype of the posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses has been developed for preteen and teenage girls aged 10 to 13 who have the early stages of scoliosis. The girdle provides a corrective force onto the torso by the warping and elastic extension of the shoulder straps and waistband and the insertion of semi-rigid EVA padding and uses a point-pressure support system to achieve the target of posture improvement and spinal progression control with physical and psychological comfort.
In order to evaluate the effectiveness of the posture correction girdle, it is proposed to recruit 10 patients to take low dose x-ray (sterEOS) at QMH at supine position. Then, the patient should wear the girdle for two hours and take another x-ray at standing position. If the Cobb's angle of the patient on girdle at standing position can be same as her supine position. It can prove the effectiveness of the girdle.
Detailed description
Background Information Scoliosis in patients between 10 and 18 years of age is termed adolescent scoliosis. The most common type of scoliosis is one of which the cause is not known. This is called "idiopathic" or "adolescent idiopathic scoliosis (AIS)". The main risk factors of curve progression could be skeletal immaturity, female gender and large curve magnitude. It has been found that nearly 10% of all adolescents have some degree of spinal curve or deformity after their tenth year. The health of patients, such as cardiac and pulmonary functions, may be affected if their spinal deformity is very serious. Hence, the most ideal way is to monitor and control spinal curvature once AIS has been found.
Treatment options for scoliosis In general, patients are suggested to undergo different types of treatments according to their spine situations and stage of scoliosis. Surgery is suggested for patients with spinal curves that are greater than 41-50 degrees, while bracing is a non-invasive treatment suggested for those with spinal curves between 21-40 degrees. Thoraco-lumber-sacral-orthosis (TLSO) or cervico-thoraco-lumbo-sacral orthosis (CTLSO) braces are the most commonly prescribed and used braces. The 3-point pressure system is primarily applied by all TLSO braces in order to correct the spinal curve and reduce the curve progression. The plaster cast is tailor-made according to the body shape of each patient. The upper torso of the wearer needs to be tightly compressed by this non-breathable material for 23 hours every day. The duration of the treatment duration will be for years until the bones are fully mature.
Aside from the fact that newer types of flexible brace products in the market are not available in large numbers, their effectiveness continues to be controversial and there is much room for improvement. The SpineCor Dynamic brace is one of the flexible braces used to treat AIS. The theory behind the SpineCor system is known as spinal coupling. Spinal coupling corrects deformities by reversing abnormal posture and body shape into their opposite position so that the abnormal alignment of the spine can be corrected. As the spinal curve of each patient is different, thus appropriate positions and tensions of the elastics will be respectively placed and adjusted by a professional before the patient wears the brace. It has been found that the curve progression rate of those who wear the SpineCor Dynamic brace is significantly higher than those who wear the rigid brace. It is believed that the ineffectiveness of the flexible brace may be caused by the shifting of the elastic bands. The elastic bands present on the brace are not fixed to the body of the wearer, and may easily shift to other areas during movement. Hence, the corrective force will no longer be exerted onto the correct position for posture and body shape correction.
A summary of the research rationale is listed below. Research rationale 1: Low treatment compliance Treatment through the use of a hard brace has low compliance due to discomfort and psychological issues, such as an awkward and bulky appearance. Flexible braces have other issues, such as discomfort caused by the elastic bands, inconvenience when going to the toilet, and unusual designs, which also result in low compliance. New designs that aim to improve compliance are therefore extremely important.
Research rationale 2: Limited product choice for adolescents with early scoliosis Hard brace treatment is overly excessive for adolescents with early scoliosis due to the high corrective force which nearly constrains all movements. The flexible brace treatment is an alternative option; however, its efficacy remains controversial. Intimate apparel that has a specialized design for teenagers with scoliosis is limited and a large majority can only provide some improvement for poor postures, such as hunchback. A scientific approach should be used to design and develop functional intimate apparel as a treatment option for adolescents with early scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients currently on underarm brace treatment will be eligible for participation in our study. For those that agree to participate, a AP/lat standing X-ray and force measurements of the brace on the rib and loin hump will be taken. They will be then be asked to wear a customised postural correction girdle 24 hours after they have taken off the brace. The same study assessments will be conducted. Patients whose forces and radiological Cobb correction are comparable between the two methods of treatment will be given a choice to either continue the hard brace or wear the posture correction girdle.
| Arm | Type | Receives |
|---|---|---|
| Posture Correction Girdle | Experimental | Device: Posture correction girdleOur research team has designed a prototype of posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses as an alternative to hard brace for AIS. The design of the posture correction girdle incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Satisfy SRS criteria for bracing15
Key exclusion criteria (7 listed)
- • Contraindications for x-ray exposure
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 |
|---|---|---|
| Posture correction girdleOur research team has designed a prototype of posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses as an alternative to hard brace for AIS. The design of the posture correction girdle incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system. | Device | Posture Correction Girdle |
Primary outcome
Measure the spinal correction of posture correction girdle and hard brace
Time frame: 2 weeks
The Cobb angle (unit: degree) of posture correction girdle and hard brace will be compared and reported.
6 secondary outcomes
Measure the pressure forces exerted by posture correction girdle and hard brace
Time frame: 2 weeks
Measure the spinal correction of posture correction girdle after 6 months
Time frame: 6 months
Measure the pressure changes of posture correction girdle after 6 months
Time frame: 6 months
Measurement of patient-related outcome of posture correction girdle and hard brace by EQ-5D-5L
Time frame: 6 months
Measurement of patient-related outcome of posture correction girdle and hard brace by SRS-22
Time frame: 6 months
Measurement of patient-related outcome of posture correction girdle and hard brace by TAPS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Adolescent Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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. This study is not recruiting at the moment.
Prof Kenneth Cheung, MBBS (UK), MD (HK) study chair
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posture correction girdle in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong 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 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenny Kwan, BMBCh (Oxon) (+852 22554654, kyhkwan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the spinal correction of posture correction girdle and hard brace (time frame: 2 weeks). 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 Nov 2021.