Clinical trial NCT06118814: Body Awareness in Adolescent Idiopatic Scoliosis
Official title: Investigation of Virtual Reality Supported Core Stabilization Exercises and Basic Body Awareness Therapy Activities in Individuals With Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis Idiopathic Adolescent
Body Image
Keywords: Scoliosis Idiopathic Adolescent
Body Awareness
Virtual Reality Exercise
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: After the power analysis, it was planned to include 40 individuals in our study, 10 individuals in each group. The groups of this study will be as follows:

* First group, virtual reality-supported core stabilization exercises (stability-enhancing exercises for the muscles around the spine) and additional home program group,
* Second group, core stabilization exercises (stability-enhancing exercises for the muscles around the spine) and additional home program group,
* Third group, basic body awareness treatment techniques and additional home program group,
* Fourth group is only home program treatment group. The treatment program is planned as a total of 20 sessions for 10 weeks, two days a week. This study was planned as single-blind to ensure the impartiality of the evaluation.

All individuals and their parents who will participate in the study will be verbally informed about the content of the study, its duration, the evaluations to be made, the treatments to be applied and the expected goals to be achieved. Signed consent forms will be obtained from the individuals and their parents indicating that they are willing to participate in the study. The sociodemographic information, physical characteristics, short leg length, age at scoliosis diagnosis, Cobb angle at first diagnosis, curve type and location results of all individuals participating in the study will be recorded. Individuals who do not want to continue the study will be excluded from the study. The study will be completed and the results will be evaluated after the final evaluations of the individuals continuing the study are completed. All participants will be re-evaluated before and after the treatment for their curve severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spinal pain, the Walter Reed Visual Assessment Scale (WRVAS), the Quality of Life Assessment Scale (SRS-22), and the Children's Depression Scale (CDI).

Eligibility criteria: 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.

Primary outcomes:
measure: Cobb Angle
timeFrame: Up to 3 months
Secondary outcomes:
measure: Walter Reed Visual Assessment Scale
timeFrame: Up to 3 months
measure: Scoliosis Research Society Questionnare
timeFrame: Change from pre treatment and post treatment.
measure: Spinal Pain Assessment
timeFrame: Up to 3 months
measure: Trunk Muscle Endurance Assessment
timeFrame: Up to 3 months
measure: Trunk Muscle Strength Assessment
timeFrame: Up to 3 months
measure: Balance Assessment
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Hitit University
Study officials:
References: