- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825159
A New Spinal Orthosis for Adolescent Idiopathic Scoliosis
A New Spinal Orthosis With an Integrated System of Electric Surface Stimulation and Heat Sensing for Adolescent Idiopathic Scoliosis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: PENGTA LIU
- Phone Number: 7427 88647238595
- Email: 105546@cch.org.tw
Study Locations
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Changhua, Taiwan, 500
- Recruiting
- Changhua Christian Hospital Taiwan
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Contact:
- Tseng
- Phone Number: 4077 886-4-7238595
- Email: tasen@cch.org.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (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°.
Exclusion Criteria:
- (1)not primary idiopathic scoliosis (2)Unable to wear the all-day brace
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ES group
Using spinal orthosis with an integrated system of electric surface stimulation and heat sensing.
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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.
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ACTIVE_COMPARATOR: brace group
Using spinal orthosis BRACE
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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base line, 6th month and 12th month
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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) |
base line, 6th month and 12th month
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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.
|
base line, 6th month and 12th month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Back muscles surface ElectroMyoGraphy (EMG)
Time Frame: base line, 6th month and 12th month
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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.
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base line, 6th month and 12th month
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Back movement pathway
Time Frame: base line, 6th month and 12th month
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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.
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base line, 6th month and 12th month
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Distributions of Pressure under the feet
Time Frame: base line, 6th month and 12th month
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Use a flat pressure mat embedded in the walkway to collect the foot pressure distribution during static standing and dynamic walking.
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base line, 6th month and 12th month
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The nerve morphological connectivity
Time Frame: base line,12th month
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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.
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base line,12th month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCH-170102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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