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

July 14, 2023 updated by: Francisco Scornavacca, Federal University of Health Science of Porto Alegre
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Recruiting
        • Hospital da Criança Santo Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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
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
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.
Other Names:
  • GRV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Timed Up and Go Test (TUG)
Time Frame: 1st and 4th postoperative day
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
Time Frame: 1st and 4th postoperative day
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)
Time Frame: until the 4th postoperative day
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
Time Frame: Baseline
Evaluated through analysis of medical records between groups.
Baseline
Sociodemographic questionnaire
Time Frame: 1st postoperative day
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)
Time Frame: 1st and 4th postoperative day
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)
Time Frame: 1st and 4th postoperative day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Collaborators

Irmandade Santa Casa de Misericórdia de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2023

Primary Completion (Estimated)

December 29, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5.930.492

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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