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Support System Design for Adolescent Scoliosis Orthosis Wear

3 maggio 2026 aggiornato da: Zhu Dian, Shanghai Jiao Tong University School of Medicine

A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback

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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

18

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200140
        • Reclutamento
        • Shanghai Jiao Tong University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Integrated Product System Intervention Arm

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.

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.

Comparatore fittizio: Conventional Treatment Control Group

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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Orthosis Wearing Compliance (Brace Adherence)
Lasso di tempo: 4 weeks
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)
Lasso di tempo: 4 weeks
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Zhao Liu, Shanghai Jiao Tong University School of Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2026

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

25 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 maggio 2026

Primo Inserito (Effettivo)

7 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NEADS006

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD will not be shared to ensure the privacy and confidentiality of the minor participants. Data access is restricted to the primary research team for the purposes of the specified study protocol.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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