NCT06118814

Brief Summary

Scoliosis is a three-dimensional deformity of the spine, and Adolescent Idiopathic Scoliosis (AIS) is the most common subtype of scoliosis. There are various scoliosis-specific exercise programs available for the treatment of scoliosis, and core stabilization is one of the methods aimed at maintaining spinal alignment. Virtual reality offers a method to create stimulating and engaging environments using task-oriented techniques to increase individual interest and motivation. In the literature, virtual reality applications have been used in healthcare to facilitate recovery, post-morbid rehabilitation, and to improve performance in athletes. However, there is limited research on the application of virtual reality therapy for scoliosis patients. One study mentioned the use of two scoliosis-specific exercises through video-assisted games, but the limited exercise repertoire did not make a significant difference. Other video-assisted studies have suggested that exercises targeting posture, balance, and gait can be used for scoliosis patients. Therefore, our study aims to apply core stabilization exercises to scoliosis patients using virtual reality applications and investigate their effects on patient development. Although studies examining the effectiveness of core stabilization exercises on body awareness in adolescents with idiopathic scoliosis are limited, they have been reported to be effective in terms of pain, body image, quality of life and functionality. This study aims to benefit from the therapeutic effects and contribute to the literature by using both different treatment methods. There are four groups in the study. Each group will be evaluated before and after ten weeks of treatment. Participants diagnosed with adolescent idiopathic scoliosis will be randomly assigned to three groups for the study. All participants will be evaluated before and after treatment for curvature severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spine pain, Cosmetic Defect Assessment-Walter Reed Visual Assessment Scale (WRVAS), Quality of Life Assessment-"Scoliosis Research Association-22" (SRS-22) and Child Depression Scale (CDI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

October 29, 2023

Last Update Submit

August 15, 2025

Conditions

Keywords

Scoliosis Idiopathic AdolescentBody AwarenessVirtual Reality Exercise

Outcome Measures

Primary Outcomes (1)

  • Cobb Angle

    Measurements are made to grade scoliosis using the frontal plane radiography using the Cobb method.

    Up to 3 months

Secondary Outcomes (6)

  • Walter Reed Visual Assessment Scale

    Up to 3 months

  • Scoliosis Research Society Questionnare

    Change from pre treatment and post treatment.

  • Spinal Pain Assessment

    Up to 3 months

  • Trunk Muscle Endurance Assessment

    Up to 3 months

  • Trunk Muscle Strength Assessment

    Up to 3 months

  • +1 more secondary outcomes

Study Arms (4)

Body Awareness Therapy Group

EXPERIMENTAL

In addition to the home program, basic body awareness exercises will be applied.

Other: Body Awareness Therapy ExerciseOther: Home Exercise

Virtual Reality Exercise Group

EXPERIMENTAL

In addition to the home program, virtual reality-supported core stabilization exercises will be applied.

Other: Virtual Reality ExerciseOther: Home Exercise

Core Stability Exercise Group

EXPERIMENTAL

In addition to the home program, core stabilization exercises will be performed.

Other: Core Stability ExerciseOther: Home Exercise

Home Exercise Group

ACTIVE COMPARATOR

A home program will be implemented.

Other: Home Exercise

Interventions

Body awareness therapy exercises were applied to the subjects in this group.

Body Awareness Therapy Group

Virtual reality exercises were applied to the subjects in this group.

Virtual Reality Exercise Group

Core stabilization exercises were applied to the subjects in this group.

Core Stability Exercise Group

Subjects in this group implemented a home exercise program.

Body Awareness Therapy GroupCore Stability Exercise GroupHome Exercise GroupVirtual Reality Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 10 and 18, having a diagnosis of AIS (Adolescent Idiopathic Scoliosis),
  • not using a brace,
  • having a Cobb angle between 10º-40º,
  • being able to regularly attend the prescribed program,
  • not having any pulmonary or thoracic cage-related diseases such as rib fractures, atelectasis, or asthma, not having any neurological or psychiatric disorders, and not having a chronic condition requiring medication, and obtaining parental consent for the child's participation in the program.

You may not qualify if:

  • The patient should not have any contraindications for exercise,
  • should not have received any scoliosis treatment or undergone spinal surgery within the last year,
  • should not be using a brace,
  • should not have scoliosis limited only to the cervical region,
  • should not have any neuromuscular, cardiovascular, or respiratory function disorder, and should not have cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University

Çorum, 19000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

August 10, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations