A New Spinal Orthosis for Adolescent Idiopathic Scoliosis

NCT03825159 | Unknown

• 1 other identifier: CCH-170102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Scoliosis; Adolescence

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  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.

  base line, 6th month and 12th month

Secondary Outcomes (4)

• Back muscles surface ElectroMyoGraphy (EMG)

  base line, 6th month and 12th month

• Back movement pathway

  base line, 6th month and 12th month

• Distributions of Pressure under the feet

  base line, 6th month and 12th month

• The nerve morphological connectivity

  base line,12th month

Study Arms (2)

ES group

EXPERIMENTAL

Using spinal orthosis with an integrated system of electric surface stimulation and heat sensing.

Device: Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing

brace group

ACTIVE COMPARATOR

Using spinal orthosis BRACE

Device: spinal orthosis

Interventions

Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing DEVICE

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.

ES group

spinal orthosis DEVICE

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.

Also known as: Scoliosis brace

brace group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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°.

You may not qualify if:

• (1)not primary idiopathic scoliosis (2)Unable to wear the all-day brace

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital Taiwan

Changhua, 500, Taiwan

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• TASEN WEI

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PENGTA LIU

CONTACT

88647238595; 105546@cch.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physian

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 31, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

TW (1)