- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06118814
Investigation of Virtual Reality Supported Core Stabilization Exercises and Basic Body Awareness Therapy Activities in Individuals With Adolescent Idiopathic Scoliosis
Scoliosis is a three-dimensional deformity of the trunk and spine, which can significantly worsen during advanced growth stages. While scoliotic deformities have various causes, approximately 80-90% of all scoliosis cases have an unknown origin and are referred to as idiopathic scoliosis. Adolescent Idiopathic Scoliosis (AIS) is the most common subtype of idiopathic scoliosis. The primary treatments for AIS include physiotherapy, bracing, and spinal surgery. Several scoliosis-specific exercise programs exist as part of physiotherapy interventions to treat scoliosis, with core stabilization being one of the methods aimed at maintaining spinal alignment.
Virtual reality is an interactive, three-dimensional simulation model created by computers that provides participants with a sense of reality and enables mutual communication. Virtual reality offers a method to create stimulating and engaging environments, using task-oriented techniques to leverage individual interests and motivation. One of the most significant advantages observed in all forms of virtual rehabilitation is its ability to promote interactivity and patient motivation. In the literature, virtual reality applications have been used in healthcare to facilitate recovery, post-illness rehabilitation, and enhance 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 resulted in no significant differences. Other video-assisted studies have suggested that exercises targeting posture, balance, and walking can be utilized 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 improvement.
While studies examining the effectiveness of core stabilization exercises on body awareness in adolescents with idiopathic scoliosis are limited, it has been reported that the basic body awareness therapy is effective in terms of pain, body image, quality of life, and functionality.
Our study aims to contribute to the literature by utilizing the therapeutic effects of both basic body awareness and virtual reality-supported exercises. The research will be conducted at Ruhi Tingiz Physical Therapy and Rehabilitation Hospital, affiliated with Amasya University Training and Research Hospital. Participants diagnosed with adolescent idiopathic scoliosis will be randomly assigned to four groups for the study. All participants' curvature severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spinal pain, Cosmetic Defect Assessment-Walter Reed Visual Assessment Scale (The Walter Reed Visual Assessment Scale (WRVAS)), Quality of Life Assessment-"Scoliosis Research Society-22" (SRS-22), and Children's Depression Scale (ÇDÖ) will be evaluated before and after treatment.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ertugrul Deniz Kose, PhDc.
- Phone Number: +905056740998
- Email: ertugrul.kose@amasya.edu.tr
Study Locations
-
-
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Corum, Turkey, 19000
- Hitit University
-
Contact:
- Ertugrul Deniz Kose, PhDc
- Phone Number: +905056740998
- Email: ertugrul.kose@amasya.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Body Awareness Therapy Group
|
Body awareness therapy exercises were applied to the subjects in this group.
Subjects in this group implemented a home exercise program.
|
Experimental: Virtual Reality Exercise Group
|
Subjects in this group implemented a home exercise program.
Virtual reality exercises were applied to the subjects in this group.
|
Experimental: Core Stability Exercise Group
|
Subjects in this group implemented a home exercise program.
Core stabilization exercises were applied to the subjects in this group.
|
Active Comparator: Home Exercise Group
|
Subjects in this group implemented a home exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cobb Angle
Time Frame: Up to 3 months
|
Measurements are made to grade scoliosis using the frontal plane radiography using the Cobb method.
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walter Reed Visual Assessment Scale
Time Frame: Up to 3 months
|
It is a scale developed to evaluate the physical deformity perceived by patients with scoliosis.
|
Up to 3 months
|
Scoliosis Research Society Questionnare
Time Frame: Change from pre treatment and post treatment.
|
It is a simple and practical quality of life questionnaire created specifically for individuals with scoliosis.
It includes parameters of pain, self-image/appearance, function/activity, mental health, and treatment satisfaction.
|
Change from pre treatment and post treatment.
|
Spinal Pain Assessment
Time Frame: Up to 3 months
|
Visual Analog Scale will be used to evaluate spinal pain.
|
Up to 3 months
|
Trunk Muscle Endurance Assessment
Time Frame: Up to 3 months
|
Straight plank and side plank tests will be used to evaluate trunk muscle endurance.
|
Up to 3 months
|
Trunk Muscle Strength Assessment
Time Frame: Up to 3 months
|
"sit-up test" and "modified push-up test" will be used to evaluate trunk flexor and extensor muscle strength.
|
Up to 3 months
|
Balance Assessment
Time Frame: Up to 3 months
|
Y balance balance test will be used for dynamic balance measurement.
|
Up to 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HititUni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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