Impact of Virtual Reality on the Postoperative Balance of Adolescents With Idiopathic Scoliosis

Study Overview
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Brief Summary
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The aim of this randomized clinical trial is to evaluate the impact of immersive virtual reality on the static and dynamic balance and functionality of adolescents with idiopathic scoliosis after spinal correction surgery. Secondarily, the objective was: (1) to analyze whether treatment with immersive virtual reality interferes with the hospitalization time of the studied population in relation to the average expected time; (2) to evaluate the impact of the use of immersive virtual reality in relation to the pain reported by adolescents with idiopathic scoliosis in the postoperative period; (3) to evaluate the impact of the use of immersive virtual reality on the functionality and quality of life of the studied population. Participants who meet the inclusion criteria will be randomized into 2 groups - virtual reality group (GRV) and control group (GC). Both groups will be assessed for pain, static and dynamic balance, length of stay, functionality and quality of life. Patients belonging to the virtual reality group will receive the intervention, which will consist of physiotherapeutic procedures usually used in the hospital applied by the institution's physiotherapist, and therapy with immersive virtual reality. The control group will receive only the physiotherapy offered by the hospital.

Detailed Description
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Introduction: Scoliosis affects between 2% and 4% of the world's pediatric population, among these, 80% have no known cause and belong to the idiopathic type of the disease. Adolescent idiopathic scoliosis (AIS), affecting individuals aged 10 to 18 years, is the most prevalent in the world. In severe cases, when the Cobb angle is greater than 50 degrees in the thoracic region and with a tendency to progression, the recommended treatment is surgery. With surgically promoted structural corrections, symptoms are often triggered, such as changes in balance. In addition to surgically triggered biomechanical changes, impairment of the somatosensory and vestibular systems and impaired neuromuscular control of the trunk, commonly associated with individuals with AIS, can influence the worsening of balance. Being determinant for the performance of different daily functional activities independently, and for the quality of human life, the rehabilitation of static and dynamic balance should be a priority in patients with adolescent idiopathic scoliosis after surgery. With an innovative technology, immersive virtual reality provides a level of realism and immersion greater than other means of virtual reality, making the user's expectations in relation to reality more congruent, and, therefore, being able to expand their motor evolution. In addition to being able to contribute to improving balance, VR is positively associated with the active engagement of individuals, improved posture and reduced apathy in performing care. Therefore, the objective of the present study is to evaluate the impact of using immersive virtual reality on the static and dynamic balance and functionality of adolescents with idiopathic scoliosis after spinal correction surgery. Justification: With the increasing insertion of virtual reality as a therapeutic tool capable of contributing to the evolution of balance and other motor skills in different populations and due to changes in balance that the surgical procedure for scoliosis correction can cause, the importance of conducting a study to assess whether virtual reality interferes with balance recovery in patients undergoing scoliosis surgery. This study may contribute to the identification of a possible treatment for the patient's functional recovery after AIS surgery. Methods: This study is characterized as a double-blind Randomized Clinical Trial with intentional sampling. Data collection will be carried out at the Santa Casa de Misericórdia Hospital Complex in Porto Alegre - Santo Antônio Children's Hospital. The activities involving the study participants will only start after approval of the project by the Research Ethics Committee of the Federal University of Health Sciences of Porto Alegre (CEP-UFCSPA) and the Irmandade da Santa Casa de Misericórdia de Porto Alegre (CEP /ISCMPA). Individuals of both sexes, aged between 11 and 18 years old, diagnosed with adolescent idiopathic scoliosis (AIS) and in the postoperative period of spine correction surgery will be included in the research. Participants who have: moderate to severe cognitive impairment will be excluded from the analysis; difficulty understanding simple orders; other physical conditions that limit trunk movements, orthostasis and/or cause pain; and medical contraindication. Participants who meet the inclusion criteria will be randomized into 2 groups - virtual reality group (GRV) and control group (GC). Data analysis will be presented through descriptive statistics appropriate to the nature and distribution of each variable. The significance level adopted for the study will be 5% (α = 0.05) and the statistical program for data analysis will be SPSS for Windows, version 25.

Official Title
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Impact of Virtual Reality on the Postoperative Balance of Adolescents With Idiopathic Scoliosis

Conditions
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Scoliosis Idiopathic

Intervention / Treatment
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* Device: Virtual reality group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals of both sexes; aged between 11 and 18 years; diagnosed with adolescent idiopathic scoliosis (AIS) and in the postoperative period of spine correction surgery. Exclusion Criteria: moderate to severe cognitive impairment; difficulty understanding simple orders; other physical conditions that limit trunk movements, orthostasis and/or cause pain; medical contraindication.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants who meet the inclusion criteria will be randomized into 2 groups - virtual reality group (GRV) and control group (GC). Both groups will undergo the same assessments and tests.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants in the control group will not receive the intervention with virtual reality, but they will also receive, on the first postoperative day, the physiotherapeutic care offered by the institution, carried out by the hospital's physiotherapist and with the same duration as the other group (GRV), and constituted by the physiotherapeutic procedures commonly used in the hospital (respiratory physiotherapy maneuvers, kinesiotherapy and walking). During each physiotherapy session, in both groups, the visual analogue scale will be applied. | |
| Experimental: Virtual reality group<br>Participants will receive the same care provided by the hospital, in addition to the application of the use of virtual reality | Device: Virtual reality group<br>* It is composed of the physiotherapeutic procedures usually used in the hospital applied by the institution's physiotherapist, and the immersive virtual reality therapy that will be conducted by a third researcher (blind to the sampling and evaluations). Physiotherapeutic consultations will have the conventional duration offered by the Institution and therapy with virtual reality will last 10 minutes, using the game Aviãozinho. Both interventions will have a frequency of 2x a day (morning and afternoon shifts), during the period of 4 days.<br>* Other names: GRV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed Up and Go Test (TUG) | Instrument that assesses dynamic balance and functional mobility. The subject starts sitting in a chair, with the back resting on the backrest and arms relaxed on the thigh. TUG measures, in seconds, the time required for the individual to get up from the chair, walk 3 meters, turn around and return to the chair, performing the 3-meter course again. | 1st and 4th postoperative day | 
| Change in Romberg Test | Its purpose is to assess static balance. To perform the test, the volunteer remains in orthostasis, barefoot, with feet parallel and together, on the ground, arms extended along the body, with eyes closed, remaining in this position for one minute | 1st and 4th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | It consists of a scale graduated from 0 to 10. The patient provides a score for his pain in a global way at the time of evaluation in each consultation, which can vary between the two extremes (0 = no pain and 10 = extreme pain). The higher the score, the worse the pain. | until the 4th postoperative day | 
| Length of stay | Evaluated through analysis of medical records between groups. | Baseline | 
| Sociodemographic questionnaire | Prepared exclusively for the study, authored by the author, consisting of questions related to personal data, family history and clinical information of the patient. | 1st postoperative day | 
| Revised Scoliosis Research Society-22 (SRS-22r) | This questionnaire has 22 questions divided into ive domains: function/activity, pain, self-image/appearance, mental health and satisfaction with management. Each domain contains ive questions, except the satisfaction with management domain, which contains two questions. Each item can be scored from 1 (worst possible) to 5 (best possible). The function/activity, pain, self-image and mental health domains have a total score ranging from 5 to 25. The satisfaction with management domain has a total score ranging from 2 to 10. | 1st and 4th postoperative day | 
| Oswestry Disability Index 2.0 (ODI) | Considered an effective method to measure disability in patients with low back pain, high severity and different causes. It is an ordinal instrument, which includes 10 criteria with six response alternatives for each criterion. The scale consists of 10 questions with six alternatives, whose value ranges from 0 to 5. | 1st and 4th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Postural Balance, Scoliosis, Pediatrics, Postoperative Period, Rehabilitation, Physical Therapy Modalities