- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Szczegółowy opis
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
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Hend Saed, Master
- Numer telefonu: 01027722937
- E-mail: hhend.samy@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Afaf Tahoon, PHD
- Numer telefonu: 01015401783
- E-mail: afaf.Tahoon@pt.cu.edu.eg
Lokalizacje studiów
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Cairo, Egipt
- Cairo University
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Kontakt:
- Hend Saed, Master
- Numer telefonu: 01027722937
- E-mail: hhend.samy@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Trunk kinematics: Trunk rotation angle (Yaw)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Trunk kinematics: trunk tilt angle (roll/ pitch)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Enas youssef, professor, Cairo University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P.T.REC/012/006415
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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