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
Visão geral do estudo
Status
Condições
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hend Saed, Master
- Número de telefone: 01027722937
- E-mail: hhend.samy@gmail.com
Estude backup de contato
- Nome: Afaf Tahoon, PHD
- Número de telefone: 01015401783
- E-mail: afaf.Tahoon@pt.cu.edu.eg
Locais de estudo
-
-
-
Cairo, Egito
- Cairo University
-
Contato:
- Hend Saed, Master
- Número de telefone: 01027722937
- E-mail: hhend.samy@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Traditional supervised exercise group
participants will perform traditional supervised Schroth physiotherapeutic scoliosis-specific exercises for 45 minutes.
|
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
|
|
Experimental: 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
|
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.
|
|
Experimental: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Trunk kinematics: Trunk rotation angle (Yaw)
Prazo: 16 weeks
|
Derived from gyroscope data(gyroZ) using wearable inertial measurement units (IMUs) to measure dynamic rotation toward midline during exercise execution.
|
16 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Trunk kinematics: trunk tilt angle (roll/ pitch)
Prazo: 16 weeks
|
derived from accelerometer data (accX, accY) using IMUs to assess frontal plane trunk asymmetry correction during exercise execution.
|
16 weeks
|
|
Trunk Kinematics: Trunk flexion/ extension angle
Prazo: 16 weeks
|
Derived from accelerometer data relative to gravity using wearable inertial measurement unit (IMUs) to monitor sagittal plane alignment during exercise execution.
|
16 weeks
|
|
Corrected posture holding time
Prazo: 16 weeks
|
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.
|
16 weeks
|
|
Health related quality of life (SRS-22r)
Prazo: 16 weeks
|
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.
|
16 weeks
|
|
pediatric health utility (EQ-5D-Y and EQ-VAS)
Prazo: 16 weeks
|
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.
|
16 weeks
|
|
Trial retention rate
Prazo: 16 weeks
|
To assess feasibility, calculated as the percentage of randomized participants who successfully complete post treatment assessment and follow-up periods.
|
16 weeks
|
|
intervention adherence rate
Prazo: 16 weeks
|
Quantified using clinic attendance logs calculated as (attended sessions / scheduled sessions)*100 to categorize participants into high, moderate or low adherence.
|
16 weeks
|
|
Safety and incidence of adverse events
Prazo: 16 weeks
|
Percentage of participants experiencing treatment related adverse events such as muscle strain or safe withdrawals from the study.
|
16 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Enas youssef, professor, Cairo University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P.T.REC/012/006415
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .