Support System Design for Adolescent Scoliosis Orthosis Wear

NCT07574229 | Recruiting DMC

• 1 other identifier: NEADS006
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Adolescent Idiopathic Scoliosis (AIS); Adherence

Outcome Measures

Primary Outcomes (2)

• Orthosis Wearing Compliance (Brace Adherence)

  The average daily wear time of the scoliosis brace, automatically recorded by the integrated pressure sensors. Compliance is calculated as the percentage of actual wear time versus the physician-recommended duration.

  4 weeks

• Intrinsic Motivation Score (IMI)

  Changes in the patient's intrinsic motivation levels as measured by the Intrinsic Motivation Inventory (IMI). This includes three specific sub-scales: Interest/Enjoyment, Perceived Competence, and Pressure/Tension (using a 7-point Likert scale).

  4 weeks

Study Arms (2)

Integrated Product System Intervention Arm

EXPERIMENTAL

Participants in this arm will use an integrated digital support system consisting of: Smart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution. Interactive Terminal: A desktop device for the home that converts sensor data into "narrative-driven" feedback with rewards. Mobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction. Psychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction.

Device: Digital Support System for AIS Orthosis Wear

Conventional Treatment Control Group

SHAM COMPARATOR

Standard Care: Participants wear their conventional spinal braces according to their physician's prescription without any electronic monitoring or feedback devices. Manual Logging: Adherence data (daily wear time) is recorded manually by patients or parents through paper diaries or self-reporting during follow-ups. Routine Clinical Support: Participants receive standard medical education and attend scheduled physical examinations and adjustments.

Behavioral: Conventional Treatment Control Group

Interventions

Digital Support System for AIS Orthosis Wear DEVICE

Smart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution. Interactive Terminal: A desktop device for the home that converts sensor data into "narrative-driven" feedback (e.g., "The Spine's Path") with rewards. Mobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction. Psychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction.

Integrated Product System Intervention Arm

Conventional Treatment Control Group BEHAVIORAL

Standard Care: Participants wear their conventional spinal braces according to their physician's prescription without any electronic monitoring or feedback devices. Manual Logging: Adherence data (daily wear time) is recorded manually by patients or parents through paper diaries or self-reporting during follow-ups. Routine Clinical Support: Participants receive standard medical education and attend scheduled physical examinations and adjustments.

Conventional Treatment Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS).
• Current orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces).
• Between 10 and 18 years of age at the time of enrollment.
• Ability to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires.
• Access to a stable home environment with Wi-Fi or local network connectivity for the interactive desktop terminal.
• Willingness of the participant to provide assent and the legal guardian to provide written informed consent.

You may not qualify if:

• Secondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome).
• Scheduled spinal surgery within the planned study period.
• Severe skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration.
• Previous participation in similar digital intervention studies for scoliosis management.
• Diagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200140, China

RECRUITING

Study Officials

• Zhao Liu

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dian Zhu, Dr

CONTACT

+8618901626266; zhudian@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Reasoning: While your project involves a device and behavioral intervention, its primary goal is to evaluate and improve the delivery of care-specifically, how to enhance treatment adherence (compliance) and the psychological experience of adolescent patients undergoing long-term orthopedic therapy.

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 7, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)