- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07794020
Virtual Reality-based Schroth Exercise Versus Traditional Schroth Exercise on Trunk Kinematics in Scoliosis
Virtual Reality-based Schroth Exercise Versus Traditional Schroth Exercise on Trunk Kinematics and Quality of Life in Scoliosis
연구 개요
상태
상세 설명
Physiotherapeutic scoliosis-specific exercises (PSSE), particularly the Schroth method, are widely recommended as a first-line conservative treatment for adolescent idiopathic scoliosis and have demonstrated effectiveness in reducing curve progression, improving posture, and enhancing quality of life. However, the long-term success of Schroth rehabilitation is highly dependent on patient adherence and the accurate execution of complex three-dimensional corrective postures, which remain challenging for adolescents to maintain outside supervised clinical settings.
Poor adherence to traditional Schroth programs has been reported, with rates ranging between 30% and 50%, limiting the real-world effectiveness of conservative scoliosis management. Adolescents frequently report low motivation, boredom, and difficulty understanding or maintaining corrective postures without continuous feedback, which compromises motor learning and postural control.
Digital rehabilitation technologies, particularly virtual reality (VR), have emerged as promising tools to enhance engagement, motivation, and motor learning in rehabilitation programs. VR-based exercise has demonstrated positive effects on adherence, movement accuracy, and postural awareness in neurological and musculoskeletal rehabilitation. Immersive VR platforms provide real-time visual and auditory feedback and promote task-oriented training in an engaging gaming environment, which is particularly suitable for adolescent populations.
To date, no randomized controlled trial has directly compared immersive high-end VR platforms with low-cost mobile VR solutions for the delivery of scoliosis-specific exercises, nor has any study quantified real-time trunk kinematics during VR-guided Schroth rehabilitation using Wearable inertial measurement units (IMUs) technology. Evaluating these interventions may provide clinicians with valuable insight into cost-effective, scalable, and engaging rehabilitation strategies for adolescents with idiopathic scoliosis, particularly in resource-limited healthcare settings
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hend Saed, Master
- 전화번호: 01027722937
- 이메일: hhend.samy@gmail.com
연구 연락처 백업
- 이름: Afaf Tahoon, PHD
- 전화번호: 01015401783
- 이메일: afaf.Tahoon@pt.cu.edu.eg
연구 장소
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Cairo, 이집트
- Cairo University
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연락하다:
- Hend Saed, Master
- 전화번호: 01027722937
- 이메일: hhend.samy@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age: 10-19 years.
- Diagnosed adolescent idiopathic scoliosis (AIS) confirmed by spinal radiography .
- Cobb angle between 20° and 35° (moderate curve, below surgical threshold).
- No prior spinal surgery.
- Ability to perform Schroth exercises independently.
- Ability to use a virtual reality headset.
- No prior virtual reality experience.
- Free from pain or pain less than 8 on visual analogue scale.
- Type of curve (thoracolumbar s scoliosis).
Exclusion Criteria:
- Secondary scoliosis (neuromuscular or post-surgical scoliosis).
- Severe structural deformity (Cobb angle >50° or severe vertebral rotation).
- Neurological or neuromuscular disorders affecting balance or proprioception.
- Active orthopedic injury or recent surgery (<2 years) involving the spine or lower extremities.
- Severe cardiopulmonary disease contraindicating exercise.
- Uncontrolled pain (Visual Analog Scale >8).
- Current participation in another structured spinal rehabilitation program or participation within the last 6 months.
- History of severe cybersickness or prior intolerance to virtual reality exposure.
- Vision or hearing impairment preventing interaction with virtual reality--based games
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Traditional supervised exercise group
participants will perform traditional supervised Schroth physiotherapeutic scoliosis-specific exercises for 45 minutes.
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participants will perform traditional supervised Schroth physiotherapeutic scoliosis-specific exercises.
The intervention consists of two supervised sessions per week, 45 minutes each, for 12 weeks
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실험적: Schroth scoliosis-specific exercises and OhShape virtual reality group
Participants will perform identical Schroth physiotherapeutic scoliosis-specific exercises in addition of integration into the OhShape virtual reality gameplay environment for 45 minutes
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participants will perform traditional supervised Schroth physiotherapeutic scoliosis-specific exercises.
The intervention consists of two supervised sessions per week, 45 minutes each, for 12 weeks
OhShape is a posture-matching rhythm-based VR game that requires users to perform precise trunk and body movements in response to visual and auditory cues, thereby promoting postural awareness, motor coordination, and movement accuracy.
The Meta Quest 2 headset provides a fully immersive virtual reality experience with six degrees of freedom (6DOF) head and body tracking, allowing real-time spatial interaction and posture-based feedback during exercise execution.
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실험적: Schroth scoliosis specific exercise and Google Cardboard Mobile virtual reality Zombie Shooter
Participants will perform identical Schroth physiotherapeutic scoliosis-specific exercises in addition of a low-cost mobile virtual reality intervention delivered via Google Cardboard for 45 minutes.
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participants will perform traditional supervised Schroth physiotherapeutic scoliosis-specific exercises.
The intervention consists of two supervised sessions per week, 45 minutes each, for 12 weeks
It is a low-cost mobile virtual reality (VR) intervention delivered via Google Cardboard.
A custom Unity-based zombie-shooting VR game will be used, in which participants are required to maintain the corrected Schroth posture while engaging in a gaze-controlled shooting task, using head and trunk alignment to aim and interact with virtual targets.
Mobile VR platforms such as Google Cardboard provide three degrees of freedom (3DOF) tracking and represent an accessible, low-cost alternative to high-end immersive VR systems.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Trunk kinematics: Trunk rotation angle (Yaw)
기간: 16 weeks
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Derived from gyroscope data(gyroZ) using wearable inertial measurement units (IMUs) to measure dynamic rotation toward midline during exercise execution.
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16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Trunk kinematics: trunk tilt angle (roll/ pitch)
기간: 16 weeks
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derived from accelerometer data (accX, accY) using IMUs to assess frontal plane trunk asymmetry correction during exercise execution.
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16 weeks
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Trunk Kinematics: Trunk flexion/ extension angle
기간: 16 weeks
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Derived from accelerometer data relative to gravity using wearable inertial measurement unit (IMUs) to monitor sagittal plane alignment during exercise execution.
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16 weeks
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Corrected posture holding time
기간: 16 weeks
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The cumulative duration (seconds ) and percentage of session time during which participants maintain the predefined curve specific corrected trunk posture within acceptable angular deviation threshold, quantified via real-time 50 Hz.
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16 weeks
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Health related quality of life (SRS-22r)
기간: 16 weeks
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Assessed using the scoliosis research society-22r questionnaire mean domain scores evaluating pain, self image, function, mental health and satisfaction.
The score is graded from 1 to 5; 1 means the worst and 5 means the best quality of life.
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16 weeks
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pediatric health utility (EQ-5D-Y and EQ-VAS)
기간: 16 weeks
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Assessed using the EuroQol 5 dimention youth version utility scores and the self rated EuroQol visual analogue scale (0-100) to measure overall health status.
0 means the worst and 100 means the best health.
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16 weeks
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Trial retention rate
기간: 16 weeks
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To assess feasibility, calculated as the percentage of randomized participants who successfully complete post treatment assessment and follow-up periods.
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16 weeks
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intervention adherence rate
기간: 16 weeks
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Quantified using clinic attendance logs calculated as (attended sessions / scheduled sessions)*100 to categorize participants into high, moderate or low adherence.
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16 weeks
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Safety and incidence of adverse events
기간: 16 weeks
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Percentage of participants experiencing treatment related adverse events such as muscle strain or safe withdrawals from the study.
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16 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Enas youssef, professor, Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
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