Actively Recruiting

Phase Not Applicable
Age: 10Years - 18Years
All Genders
NCT07574229

Support System Design for Adolescent Scoliosis Orthosis Wear

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-05-07

18

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated "Product System" designed to transform the bracing experience from a burdensome task into a guided, supportive journey. This system consists of three main components:Smart Sensing: Discrete, thin-film pressure sensors are integrated into the existing brace to monitor real-time wear time and fit quality without compromising comfort.Interactive Desktop Terminal: A dedicated device for the home that uses "narrative-driven" feedback (themed around a journey called "The Spine's Path"). Instead of cold medical data, it provides intuitive progress visualizations and rewards to keep participants engaged.Mobile Support App: A tool for both participants and parents to track long-term trends, access educational resources, and facilitate communication with healthcare providers.The Goal of the Study The primary objective is to evaluate how this digital intervention affects a participant's "Intrinsic Motivation"-the internal drive to adhere to treatment. By focusing on three psychological dimensions-Interest/Enjoyment, Perceived Competence, and Pressure/Tension-the investigators aim to determine if interactive feedback can reduce the "medical feel" of the brace and help teenagers feel more in control of the recovery.What Participation Involves Participants will use the product system during the daily routine in home and school environments. The investigators will collect objective data (brace usage hours) and subjective data (through the Intrinsic Motivation Inventory/IMI scale) to measure changes in behavior and mental well-being.Benefits for Families and ProvidersFor Participants: A more engaging, less stressful way to manage the condition and see real-time progress.For Families: Reduced friction regarding brace-wearing and better visibility into the participant's treatment status.For Healthcare Providers: Access to accurate, objective data on participant compliance, allowing for more personalized and effective clinical adjustments.

CONDITIONS

Official Title

Support System Design for Adolescent Scoliosis Orthosis Wear

Who Can Participate

Age: 10Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS)
  • Currently prescribed and using a spinal brace (e.g., Boston, Milwaukee, or similar)
  • Aged between 10 and 18 years at enrollment
  • Able to read, understand, and complete the Intrinsic Motivation Inventory and study questionnaires
  • Have access to stable home Wi-Fi or local network for the interactive terminal
  • Participant willing to assent and legal guardian able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome)
  • Scheduled spinal surgery during the study period
  • Severe skin allergies or chronic skin conditions at brace contact areas that could worsen with sensors
  • Previous participation in similar digital scoliosis intervention studies
  • Diagnosed cognitive impairments or severe psychological disorders affecting reporting or use of the system

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China, 200140

Actively Recruiting

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Research Team

D

Dian Zhu, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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