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

F

Federal University of Health Science of Porto Alegre

Status

Enrolling

Conditions

Scoliosis Idiopathic

Treatments

Device: Virtual reality group

Study type

Interventional

Funder types

Other

Identifiers

NCT05950100
5.930.492

Details and patient eligibility

About

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.

Full description

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.

Enrollment

56 estimated patients

Sex

All

Ages

11 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

56 participants in 2 patient groups

Control group
No Intervention group
Description:
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.
Virtual reality group
Experimental group
Description:
Participants will receive the same care provided by the hospital, in addition to the application of the use of virtual reality
Treatment:
Device: Virtual reality group

Trial contacts and locations

1

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Central trial contact

Scornavacca

Data sourced from clinicaltrials.gov

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