Adolescent Idiopathic ScoliosisNCT03617120
Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
A study testing Ergonomic Brace vs hard brace in people with Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects: 1. To assess the efficacy in spinal correction 2. Read more about this study
- Who is it for?
- Ages 10 to 14 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Ergonomic Brace vs hard brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2018to 31 Jan 2020
- 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 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Age 10 or older when brace is prescribed
- Risser 0 to 2
- Primary curve angles 25° to 40°
- Female, who were either pre-menarche or less than 1 year of post-menarche
- Undergoing hard brace treatment
Who cannot join
- Low risk of curve progression
- Non-idiopathic scoliosis (e.g. congenital, neuromuscular deformities)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University
Tsim Sha Tsui, Kolwoon, 00852
About this study
This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects:
- To assess the efficacy in spinal correction
- To evaluate the improvement made to the body appearance of AIS subjects
- To evaluate the impacts on the quality of life (QoL) of AIS subjects
All participants will be fitted with an Ergonomic Brace and required to wear it during the days of experiment only. The ongoing treatment with hard brace will not be substituted with the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.
Read the detailed description
- To assess the efficacy in spinal correction The efficacy of the Ergonomic Brace refers to the magnitude of spinal correction that could be obtained for patients with AIS. The assessments in this study focus on two aspects, which are i) the in-brace correction and ii) the interface pressure. In-brace correction is used to judge the quality of bracing and also a prognostic indicator for the long-term treatment outcome. Clinical parameters such as Cobb angle, vertebral rotation and trunk listing will be measured with radiographs by a single observer. Interface pressure in this study refers to the pressure between the brace and the trunk of subject. The purpose is to assess the time response of trunk to the intervention of the Ergonomic Brace, and correlation will also be made with the extent of spinal correction.
- To evaluate the improvement made to the body appearance of AIS subjects The trunk aesthetic profile of AIS subjects are being affected by spinal deformities. Surface topography of the subjects will be captured by 3D body scanner, and followed by the evaluation of body aesthetics through the trunk asymmetry scales called POTSI and ATSI index. The purpose is to compare the surface topography change before and after wearing the Ergonomic Brace.
- To evaluate the impacts on the QoL of AIS subjects
Bracing can negatively affect the QoL of patients with AIS. The Chinese version of Brace Questionnaire (BrQ) will be adopted in this study to compare the impact of hard brace and Ergonomic Brace on the QoL of AIS subjects. Difficulties experienced by AIS subjects during bracing will be highlighted and used for future improvements in scoliosis brace design.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Ergonomic Brace vs hard brace
- Keywords
- Scoliosis brace, Conventional treatment for Adolescent Idiopathic Scoliosis, In-brace correction, Trunk listing, Vertebral rotation, Interface pressure, 3D body scanning, Surface topography, Trunk asymmetry, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic Brace vs hard braceDevice
Visit 1:
- Usual check-up: standing in-brace radiograph of hard brace and doctor consultation
- Pressure measurement of participant wearing their hard brace
Visit 2:
- Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS)
- 3D body scanning (before wearing the Ergonomic Brace)
- Fitting of the Ergonomic Brace
- Pressure measurement of participant wearing the Ergonomic Brace (instant)
- Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours)
- 3D body scanning (after wearing the Ergonomic Brace for 2 hours)
- Brace Questionnaire (BrQ) for the Ergonomic Brace
Visit 3:
- Standing in-brace radiograph of the Ergonomic Brace
- Doctor consultation
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic Brace vs hard brace | Experimental | Ergonomic Brace is a new design of scoliosis brace, which consists of a knit bodice as base and also resin bones, paddings, straps and a pelvic belt as auxiliaries for spinal correction. The purpose of the bones is to keep the posture of patient upright. Paddings are placed at the convex regions of the spine while straps are used to input directional force onto the paddings. Pelvic belt, on the other hand, is for stabilizing the pelvis in order to achieve an effective spinal correction. The biomechanical principles for the correction of spine has considered both the frontal and sagittal planes, where the overall brace mechanism follows the Rigo classification.
Hard brace is the brace which the participants are currently using for their ongoing conservative treatment. Receives: Device: Ergonomic Brace vs hard brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate in-brace correction of spinal curve
Cobb angle: more than/equal to 40% correction (lumbar/thoracolumbar curve); slightly less than/close to 40% correction (thoracic curve)
Measured: 2 hours
Secondary outcomes (4)
Immediate in-brace correction of vertebral rotation assessed by the Global Torsion Index
Global torsion index: to quantify detorsion by averaging the 17 segmental rotations of thoracic and lumbar vertebrae
- Higher index score = the average segmental rotations of the 17 vertebrae is higher;
- Lower index score = the average segmental rotations of the 17 vertebrae is lower
The global torsion index which result from wearing the Ergonomic Brace will be compared with which of hard brace. A higher/similar detorsion percentage as hard brace is considered satisfactory.
Measured: 2 hours
Immediate in-brace correction of trunk listing assessed by the plumb line method
Plumb line method: to assess the coronal and sagittal balance by drawing a vertical line from the mid-point of the C7 vertebra down to the sacrum
- Positive balance: the plumb line passes more than 2 cm in front of the posterosuperior corner of the S1 vertebral body
- Neutral balance: the plumb line passes within 2 cm of the posterosuperior corner of the S1 vertebral body
- Negative balance: the plumb line passes more than 2 cm behind the posterosuperior corner of the S1 vertebral body
Measurement of trunk listing is significant in the treatment of scoliosis curve, as it is related to the trunk aesthetic profile of the subjects, and besides, sagittal balance of the spine and pelvis is correlated with the progression of scoliosis. An improvement in the coronal and sagittal balance of spine resulting from wearing the Ergonomic Brace is therefore considered satisfactory.
Measured: 2 hours
Improvement in trunk asymmetry assessed by the POTSI index
Posterior Trunk Symmetry Index (POTSI): to compare the surface topography change before and after wearing the Ergonomic Brace POTSI index: a parameter used for assessing the trunk asymmetry and deformity in the coronal plane All measurements will be performed on the 3D surface topography scans. Ideal value of POTSI is zero, meaning full asymmetry of the posterior and anterior trunk respectively.
Normal value of POTSI should lie below 27. The performance of the Ergonomic Brace in terms of improving the trunk asymmetry of participants is considered effective when the index is scored within normal value (i.e. 0-27).
Measured: 0 and 6 month
Improvement in trunk asymmetry assessed by the ATSI index
Anterior Trunk Symmetry Index (ASTI): to compare the surface topography change before and after wearing the Ergonomic Brace ATSI index: a parameter used for assessing the trunk asymmetry and deformity in the frontal plane All measurements will be performed on the 3D surface topography scans. Ideal value of ATSI is zero, meaning full asymmetry of the posterior and anterior trunk respectively. Normal value, on the other hand, should lie below 27 for each index. The performance of the Ergonomic Brace in terms of improving the trunk asymmetry of participants is considered effective when the index is scored within normal value (i.e. 0-27).
Measured: 0 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong, The University of Hong Kong
- Responsible party
- Principal investigator, Joanne Yip, The Hong Kong Polytechnic University
- Investigators
- Joanne Yip, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617120
- Sponsor's protocol ID
- ITS/297/16
- Status last verified
- Feb 2020
- First submitted
- 25 Jul 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03617120
- Acronym / sponsor ID
- ITS/297/16
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis brace, Conventional treatment for Adolescent Idiopathic Scoliosis, In-brace correction, Trunk listing, Vertebral rotation, Interface pressure, 3D body scanning, Surface topography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong, The University of Hong Kong
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 6 Aug 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.
This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects:
- To assess the efficacy in spinal correction
- To evaluate the improvement made to the body appearance of AIS subjects
- To evaluate the impacts on the quality of life (QoL) of AIS subjects
All participants will be fitted with an Ergonomic Brace and required to wear it during the days of experiment only. The ongoing treatment with hard brace will not be substituted with the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.
Detailed description
- To assess the efficacy in spinal correction The efficacy of the Ergonomic Brace refers to the magnitude of spinal correction that could be obtained for patients with AIS. The assessments in this study focus on two aspects, which are i) the in-brace correction and ii) the interface pressure. In-brace correction is used to judge the quality of bracing and also a prognostic indicator for the long-term treatment outcome. Clinical parameters such as Cobb angle, vertebral rotation and trunk listing will be measured with radiographs by a single observer. Interface pressure in this study refers to the pressure between the brace and the trunk of subject. The purpose is to assess the time response of trunk to the intervention of the Ergonomic Brace, and correlation will also be made with the extent of spinal correction.
- To evaluate the improvement made to the body appearance of AIS subjects The trunk aesthetic profile of AIS subjects are being affected by spinal deformities. Surface topography of the subjects will be captured by 3D body scanner, and followed by the evaluation of body aesthetics through the trunk asymmetry scales called POTSI and ATSI index. The purpose is to compare the surface topography change before and after wearing the Ergonomic Brace.
- To evaluate the impacts on the QoL of AIS subjects
Bracing can negatively affect the QoL of patients with AIS. The Chinese version of Brace Questionnaire (BrQ) will be adopted in this study to compare the impact of hard brace and Ergonomic Brace on the QoL of AIS subjects. Difficulties experienced by AIS subjects during bracing will be highlighted and used for future improvements in scoliosis brace design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ergonomic Brace vs hard brace | Experimental | Device: Ergonomic Brace vs hard braceErgonomic Brace is a new design of scoliosis brace, which consists of a knit bodice as base and also resin bones, paddings, straps and a pelvic belt as auxiliaries for spinal correction. The purpose of the bones is to keep the posture of patient upright. Paddings are placed at the convex regions of the spine while straps are used to input directional force onto the paddings. Pelvic belt, on the other hand, is for stabilizing the pelvis in order to achieve an effective spinal correction. The biomechanical principles for the correction of spine has considered both the frontal and sagittal planes, where the overall brace mechanism follows the Rigo classification. Hard brace is the brace which the participants are currently using for their ongoing conservative treatment. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 10 or older when brace is prescribed
- Risser 0 to 2
- Primary curve angles 25° to 40°
- Female, who were either pre-menarche or less than 1 year of post-menarche
- Undergoing hard brace treatment
Key exclusion criteria (2 listed)
- Low risk of curve progression
- Non-idiopathic scoliosis (e.g. congenital, neuromuscular deformities)
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 |
|---|---|---|
| Ergonomic Brace vs hard braceVisit 1: 1. Usual check-up: standing in-brace radiograph of hard brace and doctor consultation 2. Pressure measurement of participant wearing their hard brace Visit 2: 1. Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS) 2. 3D body scanning (before wearing the Ergonomic Brace) 3. Fitting of the Ergonomic Brace 4. Pressure measurement of participant wearing the Ergonomic Brace (instant) 5. Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours) 6. 3D body scanning (after wearing the Ergonomic Brace for 2 hours) 7. Brace Questionnaire (BrQ) for the Ergonomic Brace Visit 3: 1. Standing in-brace radiograph of the Ergonomic Brace 2. Doctor consultation | Device | Ergonomic Brace vs hard brace |
Primary outcome
Immediate in-brace correction of spinal curve
Time frame: 2 hours
Cobb angle: more than/equal to 40% correction (lumbar/thoracolumbar curve); slightly less than/close to 40% correction (thoracic curve)
4 secondary outcomes
Immediate in-brace correction of vertebral rotation assessed by the Global Torsion Index
Time frame: 2 hours
Immediate in-brace correction of trunk listing assessed by the plumb line method
Time frame: 2 hours
Improvement in trunk asymmetry assessed by the POTSI index
Time frame: 0 and 6 month
Improvement in trunk asymmetry assessed by the ATSI index
Time frame: 0 and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
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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. This study is not recruiting at the moment.
Joanne Yip 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 Ergonomic Brace vs hard brace in people with 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 2 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: finished, as of the sponsor's last update on 12 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate in-brace correction of spinal curve (time frame: 2 hours). 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 12 Feb 2020.