Scoliosis; AdolescenceNCT03825159
A New Spinal Orthosis for Adolescent Idiopathic Scoliosis
A study testing Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing and spinal orthosis in people with Scoliosis; Adolescence, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
The new device with digital technology provides a new avenue to enable clinicians to communicate wirelessly with the imbedded core system such that they can adjust the electrical stimulation parameters and retrieve the temperature data for further compliance analysis. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Scoliosis; Adolescence
- What is being tested?
- Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing and spinal orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2019to 31 Jan 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (1) the range of age should be from ten years old to seventeen years old and (2) the Cobb angle should be from 20°to 45°.
Who cannot join
- (1)not primary idiopathic scoliosis (2)Unable to wear the all-day brace
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital Taiwan
Changhua, 500
Tseng, 886-4-7238595 ext. 4077, tasen@cch.org.tw
Tasen Wei
About this study
Official title: A New Spinal Orthosis With an Integrated System of Electric Surface Stimulation and Heat Sensing for Adolescent Idiopathic Scoliosis
The new device with digital technology provides a new avenue to enable clinicians to communicate wirelessly with the imbedded core system such that they can adjust the electrical stimulation parameters and retrieve the temperature data for further compliance analysis. The smart phone and cloud technology can be effectively applied for both security and convenience. The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process. The electrical stimulation is purposely to tone the muscle in order to replace the external mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may maintain the correction.
Read the detailed description
Spinal orthosis is an option to treat Adolescent Idiopathic Scoliosis (AIS) and is the most commonly used among conservative treatment. According to Scoliosis Research Society (SRS), orthotic treatment is indicated for AIS patients with curves greater than 25˚ but smaller than 45˚. However, the in-brace correction is hardly maintained and the effectiveness of orthotic treatment is limited, which has been an impetus to develop a more effective method for AIS patients to fulfill the unmet need. In order the orthosis is effective, biomechanical intervention and the patient compliance are two key factors. The purpose of this two-year project is to develop a new spinal orthosis in which an integrated system of electric surface stimulation and heat sensing is imbedded such that the AIS will be effectively treated with the mechanical orthosis plus a nocturnal use of electrical stimulation. In addition to the already stellar device, a totally new concept of spine erectability is proposed to provide evidence that can manifest the unique value of orthotic treatment as opposed to surgery. It is hypothesized that the new spinal orthosis would not only reduce the Cobb angle and apical rotation but also would strengthen the spine erectability in AIS patients. The new device with digital technology provides a new avenue to enable clinicians to communicate wirelessly with the imbedded core system such that they can adjust the electrical stimulation parameters and retrieve the temperature data for further compliance analysis. The smart phone and cloud technology can be effectively applied for both security and convenience. The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process. The electrical stimulation is purposely to tone the muscle in order to replace the external mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may maintain the correction. With the spinal orthosis, the applied current in stimulation process would be reduced and the skin irritation would too. First year, there will be three tasks. An instrument will be developed for clinicians to assess the applicability of electrical surface stimulation to each AIS patient. System integration of the spinal orthosis with electrical surface stimulation and heat sensing will be accomplished. Clinical study of the effectiveness of passive spinal orthoses on 30 AIS subjects as a control group, where the Cobb angle, apical rotation and spine erectability will be measured before treatment and after. Second year, another 30 AIS patients will be recruited; the applicability of electrical surface stimulation will be assessed; and the new spinal orthosis will be applied to the experiment group. The Cobb angle, apical rotation and spine erectability will be measured before treatment and after for each subject. Independent t test will be carried out for the two groups to test the hypothesis.
- Conditions
- Scoliosis; Adolescence
- Being tested
- Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing, spinal orthosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat SensingDevice
The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process.
spinal orthosisDevice
Also called Scoliosis brace
The ventrally opened total contact spinal orthosis will be designed and made of Copolymer and Aliplast. Correcting pressure points have to use the pressure pads at relevant points.
| Study group | Role | What they receive |
|---|---|---|
| ES group | Experimental | Using spinal orthosis with an integrated system of electric surface stimulation and heat sensing. Receives: Device: Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing |
| brace group | Active comparator | Using spinal orthosis BRACE Receives: Device: spinal orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Cobb angle
When measuring Cobb angle, the investigators should identify the upper and lower end vertebra. Then, the investigators draw perpendicular lines extending along the vertebral borders. The angle where two perpendicular lines meet is called Cobb angle
Measured: base line, 6th month and 12th month
Change of Spine erectability
Spine erectability is to define the physiological ability of the spine to maintain it erect against gravity and will be assessed without wearing orthoses.
The force F acting at the apex is the weights of the head and two upper limbs plus 7/17 trunk weight, which can be calculated with the readily available anthropometric data. The bending moment M at T8 equals the applied force F multiplies the lever arm d, which is the distance between the force and the weight line.
SE=(Weight*7/17)*d/(Cobb angle in standing-Cobb angle in supine)
Measured: base line, 6th month and 12th month
Change of Apical rotation
Apical rotation is the degree of apical vertebral rotation .The Raimondi method uses the projection of the vertebral pedicles and the width of the vertebra as a reference for the measuring. The largest axis of the pedicle is demarcated and measured on the side of the curve convexity, and the distance of the longitudinal line from the pedicle to the border of the vertebra on the convex side is measured. Those two values are transported to the ruler, and the value of the rotation is obtained.
Measured: base line, 6th month and 12th month
Secondary outcomes (4)
Back muscles surface ElectroMyoGraphy (EMG)
Use a non-invasive surface EMG tool to collect muscle activities on the upper and lower back area, while the subject performs the trunk flexion-extension-lateral rotation with standing posture.
Measured: base line, 6th month and 12th month
Back movement pathway
Use cameras to record the back motion pathway during trunk flexion-extension \& lateral rotations, while the subject performs the trunk flexion-extension-lateral rotation with standing posture.
Measured: base line, 6th month and 12th month
Distributions of Pressure under the feet
Use a flat pressure mat embedded in the walkway to collect the foot pressure distribution during static standing and dynamic walking.
Measured: base line, 6th month and 12th month
The nerve morphological connectivity
The subject's diffusion tensor features are extracted from functional Magnetic Resonance Imaging of head. The features would include the never connectivity, pathway, the size of nuclei.
Measured: base line,12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
- Investigators
- TASEN WEI, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825159
- Sponsor's protocol ID
- CCH-170102
- Status last verified
- Jun 2021
- First submitted
- 30 Dec 2018
- Last updated
- 2 Jul 2021
- 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 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Spinal Orthosis With an Integrated System of Electric Surface Stimulation and Heat Sensing for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03825159
- Acronym / sponsor ID
- CCH-170102
- Conditions
- Scoliosis; Adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 31 Jan 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.
The new device with digital technology provides a new avenue to enable clinicians to communicate wirelessly with the imbedded core system such that they can adjust the electrical stimulation parameters and retrieve the temperature data for further compliance analysis. The smart phone and cloud technology can be effectively applied for both security and convenience. The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process. The electrical stimulation is purposely to tone the muscle in order to replace the external mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may maintain the correction.
Detailed description
Spinal orthosis is an option to treat Adolescent Idiopathic Scoliosis (AIS) and is the most commonly used among conservative treatment. According to Scoliosis Research Society (SRS), orthotic treatment is indicated for AIS patients with curves greater than 25˚ but smaller than 45˚. However, the in-brace correction is hardly maintained and the effectiveness of orthotic treatment is limited, which has been an impetus to develop a more effective method for AIS patients to fulfill the unmet need. In order the orthosis is effective, biomechanical intervention and the patient compliance are two key factors. The purpose of this two-year project is to develop a new spinal orthosis in which an integrated system of electric surface stimulation and heat sensing is imbedded such that the AIS will be effectively treated with the mechanical orthosis plus a nocturnal use of electrical stimulation. In addition to the already stellar device, a totally new concept of spine erectability is proposed to provide evidence that can manifest the unique value of orthotic treatment as opposed to surgery. It is hypothesized that the new spinal orthosis would not only reduce the Cobb angle and apical rotation but also would strengthen the spine erectability in AIS patients. The new device with digital technology provides a new avenue to enable clinicians to communicate wirelessly with the imbedded core system such that they can adjust the electrical stimulation parameters and retrieve the temperature data for further compliance analysis. The smart phone and cloud technology can be effectively applied for both security and convenience. The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process. The electrical stimulation is purposely to tone the muscle in order to replace the external mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may maintain the correction. With the spinal orthosis, the applied current in stimulation process would be reduced and the skin irritation would too. First year, there will be three tasks. An instrument will be developed for clinicians to assess the applicability of electrical surface stimulation to each AIS patient. System integration of the spinal orthosis with electrical surface stimulation and heat sensing will be accomplished. Clinical study of the effectiveness of passive spinal orthoses on 30 AIS subjects as a control group, where the Cobb angle, apical rotation and spine erectability will be measured before treatment and after. Second year, another 30 AIS patients will be recruited; the applicability of electrical surface stimulation will be assessed; and the new spinal orthosis will be applied to the experiment group. The Cobb angle, apical rotation and spine erectability will be measured before treatment and after for each subject. Independent t test will be carried out for the two groups to test the hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES group | Experimental | Device: Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat SensingUsing spinal orthosis with an integrated system of electric surface stimulation and heat sensing. |
| brace group | Active comparator | Device: spinal orthosisUsing spinal orthosis BRACE |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (1) the range of age should be from ten years old to seventeen years old and (2) the Cobb angle should be from 20°to 45°.
Key exclusion criteria (1 listed)
- (1)not primary idiopathic scoliosis (2)Unable to wear the all-day brace
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 |
|---|---|---|
| Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat SensingThe electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process. | Device | ES group |
| spinal orthosisAlso: Scoliosis braceThe ventrally opened total contact spinal orthosis will be designed and made of Copolymer and Aliplast. Correcting pressure points have to use the pressure pads at relevant points. | Device | brace group |
Primary outcome
Change of Cobb angle
Time frame: base line, 6th month and 12th month
When measuring Cobb angle, the investigators should identify the upper and lower end vertebra. Then, the investigators draw perpendicular lines extending along the vertebral borders. The angle where two perpendicular lines meet is called Cobb angle
Change of Spine erectability
Time frame: base line, 6th month and 12th month
Spine erectability is to define the physiological ability of the spine to maintain it erect against gravity and will be assessed without wearing orthoses. The force F acting at the apex is the weights of the head and two upper limbs plus 7/17 trunk weight, which can be calculated with the readily available anthropometric data. The bending moment M at T8 equals the applied force F multiplies the lever arm d, which is the distance between the force and the weight line. SE=(Weight*7/17)*d/(Cobb angle in standing-Cobb angle in supine)
Change of Apical rotation
Time frame: base line, 6th month and 12th month
Apical rotation is the degree of apical vertebral rotation .The Raimondi method uses the projection of the vertebral pedicles and the width of the vertebra as a reference for the measuring. The largest axis of the pedicle is demarcated and measured on the side of the curve convexity, and the distance of the longitudinal line from the pedicle to the border of the vertebra on the convex side is measured. Those two values are transported to the ruler, and the value of the rotation is obtained.
4 secondary outcomes
Back muscles surface ElectroMyoGraphy (EMG)
Time frame: base line, 6th month and 12th month
Back movement pathway
Time frame: base line, 6th month and 12th month
Distributions of Pressure under the feet
Time frame: base line, 6th month and 12th month
The nerve morphological connectivity
Time frame: base line,12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
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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.
TASEN WEI principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing and spinal orthosis in people with Scoliosis; Adolescence, run by Changhua Christian Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 2 Jul 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 Taiwan. 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 PENGTA LIU (88647238595 ext. 7427, 105546@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cobb angle (time frame: base line, 6th month and 12th month). The study lists 3 primary outcomes in all. 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 2 Jul 2021.