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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06118814
Other study ID # HititUni
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source Hitit University
Contact Ertugrul Deniz Kose, PhDc.
Phone +905056740998
Email ertugrul.kose@amasya.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 30, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Body Awareness Therapy Exercise
Body awareness therapy exercises were applied to the subjects in this group.
Virtual Reality Exercise
Virtual reality exercises were applied to the subjects in this group.
Core Stability Exercise
Core stabilization exercises were applied to the subjects in this group.
Home Exercise
Subjects in this group implemented a home exercise program.

Locations

Country Name City State
Turkey Hitit University Corum

Sponsors (1)

Lead Sponsor Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cobb Angle Measurements are made to grade scoliosis using the frontal plane radiography using the Cobb method. Up to 3 months
Secondary Walter Reed Visual Assessment Scale It is a scale developed to evaluate the physical deformity perceived by patients with scoliosis. Up to 3 months
Secondary Scoliosis Research Society Questionnare 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.
Secondary Spinal Pain Assessment Visual Analog Scale will be used to evaluate spinal pain. Up to 3 months
Secondary Trunk Muscle Endurance Assessment Straight plank and side plank tests will be used to evaluate trunk muscle endurance. Up to 3 months
Secondary Trunk Muscle Strength Assessment "sit-up test" and "modified push-up test" will be used to evaluate trunk flexor and extensor muscle strength. Up to 3 months
Secondary Balance Assessment Y balance balance test will be used for dynamic balance measurement. Up to 3 months
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