- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dian Zhu, Dr
- 전화번호: +8618901626266
- 이메일: zhudian@sjtu.edu.cn
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200140
- 모병
- Shanghai Jiao Tong University
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연락하다:
- Zhao Liu
- 전화번호: 18801971294
- 이메일: hotlz@sjtu.edu.cn
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-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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가짜 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Orthosis Wearing Compliance (Brace Adherence)
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Zhao Liu, Shanghai Jiao Tong University School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NEADS006
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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