- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hend Saed, Master
- Telefonnummer: 01027722937
- E-mail: hhend.samy@gmail.com
Undersøgelse Kontakt Backup
- Navn: Afaf Tahoon, PHD
- Telefonnummer: 01015401783
- E-mail: afaf.Tahoon@pt.cu.edu.eg
Studiesteder
-
-
-
Cairo, Egypten
- Cairo University
-
Kontakt:
- Hend Saed, Master
- Telefonnummer: 01027722937
- E-mail: hhend.samy@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Trunk kinematics: Trunk rotation angle (Yaw)
Tidsramme: 16 weeks
|
Derived from gyroscope data(gyroZ) using wearable inertial measurement units (IMUs) to measure dynamic rotation toward midline during exercise execution.
|
16 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Trunk kinematics: trunk tilt angle (roll/ pitch)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 16 weeks
|
Percentage of participants experiencing treatment related adverse events such as muscle strain or safe withdrawals from the study.
|
16 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Enas youssef, professor, Cairo University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P.T.REC/012/006415
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .