Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Support System Design for Adolescent Scoliosis Orthosis Wear

3. maj 2026 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200140
        • Rekruttering
        • Shanghai Jiao Tong University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Sham-komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Orthosis Wearing Compliance (Brace Adherence)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Zhao Liu, Shanghai Jiao Tong University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

25. april 2026

Først indsendt, der opfyldte QC-kriterier

3. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NEADS006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Digital Support System for AIS Orthosis Wear

Abonner