NCT07794020

Brief Summary

The study will be conducted to compare three-dimensional trunk kinematics (rotation, tilt, and flexion/extension) and quality of life among adolescents with idiopathic scoliosis receiving traditional Schroth physiotherapeutic scoliosis-specific exercises, Schroth exercises combined with immersive virtual reality using Meta Quest 2 (OhShape), and Schroth exercises combined with low-cost mobile virtual reality using Google Cardboard with a gaze-controlled game.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Sep 2026Feb 2027

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

ScoliosisScoliosis Idiopathic

Keywords

virtual realityScoliosis

Outcome Measures

Primary Outcomes (1)

  • Trunk kinematics: Trunk rotation angle (Yaw)

    Derived from gyroscope data(gyroZ) using wearable inertial measurement units (IMUs) to measure dynamic rotation toward midline during exercise execution.

    16 weeks

Secondary Outcomes (8)

  • Trunk kinematics: trunk tilt angle (roll/ pitch)

    16 weeks

  • Trunk Kinematics: Trunk flexion/ extension angle

    16 weeks

  • Corrected posture holding time

    16 weeks

  • Health related quality of life (SRS-22r)

    16 weeks

  • pediatric health utility (EQ-5D-Y and EQ-VAS)

    16 weeks

  • +3 more secondary outcomes

Study Arms (3)

Traditional supervised exercise group

ACTIVE COMPARATOR

participants will perform traditional supervised Schroth physiotherapeutic scoliosis-specific exercises for 45 minutes.

Other: Traditional schroth supervised exercise

Schroth scoliosis-specific exercises and OhShape virtual reality group

EXPERIMENTAL

Participants will perform identical Schroth physiotherapeutic scoliosis-specific exercises in addition of integration into the OhShape virtual reality gameplay environment for 45 minutes

Other: Traditional schroth supervised exerciseOther: OhShape virtual reality gameplay environment

Schroth scoliosis specific exercise and Google Cardboard Mobile virtual reality Zombie Shooter

EXPERIMENTAL

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.

Other: Traditional schroth supervised exerciseOther: Google Cardboard Mobile Virtual reality Zombie Shooter

Interventions

Traditional schroth supervised exerciseOTHER

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

Schroth scoliosis specific exercise and Google Cardboard Mobile virtual reality Zombie ShooterSchroth scoliosis-specific exercises and OhShape virtual reality groupTraditional supervised exercise group
OhShape virtual reality gameplay environmentOTHER

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.

Schroth scoliosis-specific exercises and OhShape virtual reality group
Google Cardboard Mobile Virtual reality Zombie ShooterOTHER

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.

Schroth scoliosis specific exercise and Google Cardboard Mobile virtual reality Zombie Shooter

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Enas youssef, professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Hend Saed, Master

CONTACT

01027722937hhend.samy@gmail.com

Afaf Tahoon, PHD

CONTACT

01015401783afaf.Tahoon@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

August 31, 2026

Record last verified: 2026-08

Locations

EG(1)