A New Spinal Orthosis for Adolescent Idiopathic Scoliosis

NCT ID: NCT03825159

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2023-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ES group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

brace group

Using spinal orthosis BRACE

Group Type: ACTIVE_COMPARATOR

spinal orthosis

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

spinal orthosis

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.

Intervention Type: DEVICE

Other Intervention Names

Scoliosis brace

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ta-Sen Wei,MD

physian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TASEN WEI

Role: PRINCIPAL_INVESTIGATOR

Changhua Christian Hospital

Locations

Changhua Christian Hospital Taiwan

Changhua, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

PENGTA LIU

Role: CONTACT

105546@cch.org.tw

88647238595 ext. 7427

Facility Contacts

Tseng

Role: primary

tasen@cch.org.tw

886-4-7238595 ext. 4077

Other Identifiers

CCH-170102

Identifier Type: -

Identifier Source: org_study_id