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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07574229
Support System Design for Adolescent Scoliosis Orthosis Wear
A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Dian Zhu, Dr
- Numero di telefono: +8618901626266
- Email: zhudian@sjtu.edu.cn
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200140
- Reclutamento
- Shanghai Jiao Tong University
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Contatto:
- Zhao Liu
- Numero di telefono: 18801971294
- Email: hotlz@sjtu.edu.cn
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
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
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 |
|---|---|
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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. |
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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 |
|---|---|---|
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Orthosis Wearing Compliance (Brace Adherence)
Lasso di tempo: 4 weeks
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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.
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4 weeks
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Intrinsic Motivation Score (IMI)
Lasso di tempo: 4 weeks
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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).
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4 weeks
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Zhao Liu, Shanghai Jiao Tong University School of Medicine
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NEADS006
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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