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A New Spinal Orthosis for Adolescent Idiopathic Scoliosis

NCT03825159 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-07-02

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Changhua Christian Hospital

    lead OTHER

Principal Investigators

  • TASEN WEI · Changhua Christian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825159 on ClinicalTrials.gov