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Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis

NCT03617120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-02-12

No results posted yet for this study

Summary

This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects:

1. To assess the efficacy in spinal correction
2. To evaluate the improvement made to the body appearance of AIS subjects
3. To evaluate the impacts on the quality of life (QoL) of AIS subjects

All participants will be fitted with an Ergonomic Brace and required to wear it during the days of experiment only. The ongoing treatment with hard brace will not be substituted with the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DEVICE

Ergonomic Brace vs hard brace

Visit 1: 1. Usual check-up: standing in-brace radiograph of hard brace and doctor consultation 2. Pressure measurement of participant wearing their hard brace Visit 2: 1. Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS) 2. 3D body scanning (before wearing the Ergonomic Brace) 3. Fitting of the Ergonomic Brace 4. Pressure measurement of participant wearing the Ergonomic Brace (instant) 5. Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours) 6. 3D body scanning (after wearing the Ergonomic Brace for 2 hours) 7. Brace Questionnaire (BrQ) for the Ergonomic Brace Visit 3: 1. Standing in-brace radiograph of the Ergonomic Brace 2. Doctor consultation

Sponsors & Collaborators

  • Innovation and Technology Commission, Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    collaborator OTHER

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Joanne Yip · The Hong Kong Polytechnic University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-12-31
Completion
2020-01-31

Countries

  • Hong Kong

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 NCT03617120 on ClinicalTrials.gov