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

Primary Purpose

Scoliosis Idiopathic

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Virtual reality group
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring Virtual Reality, Postural Balance, Scoliosis, Pediatrics, Postoperative Period, Rehabilitation, Physical Therapy Modalities

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital da Criança Santo AntônioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Virtual reality group

Arm 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.

Participants will receive the same care provided by the hospital, in addition to the application of the use of virtual reality

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
Length of stay
Evaluated through analysis of medical records between groups.
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.
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.
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.

Full Information

First Posted
July 5, 2023
Last Updated
July 14, 2023
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05950100
Brief Title
Impact of Virtual Reality on the Postoperative Balance of Adolescents With Idiopathic Scoliosis
Official Title
Impact of Virtual Reality on the Postoperative Balance of Adolescents With Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2023 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic
Keywords
Virtual Reality, Postural Balance, Scoliosis, Pediatrics, Postoperative Period, Rehabilitation, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The first researcher who will follow the draw will be blinded to the patients' assessments and to the intervention. The second researcher who will evaluate the two groups will be blind to sampling and intervention. And the immersive virtual reality therapy will be conducted by a third researcher (blinded to sampling and assessments).
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
Participants will receive the same care provided by the hospital, in addition to the application of the use of virtual reality
Intervention Type
Device
Intervention Name(s)
Virtual reality group
Other Intervention Name(s)
GRV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Timed Up and Go Test (TUG)
Description
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.
Time Frame
1st and 4th postoperative day
Title
Change in Romberg Test
Description
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
Time Frame
1st and 4th postoperative day
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
until the 4th postoperative day
Title
Length of stay
Description
Evaluated through analysis of medical records between groups.
Time Frame
Baseline
Title
Sociodemographic questionnaire
Description
Prepared exclusively for the study, authored by the author, consisting of questions related to personal data, family history and clinical information of the patient.
Time Frame
1st postoperative day
Title
Revised Scoliosis Research Society-22 (SRS-22r)
Description
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.
Time Frame
1st and 4th postoperative day
Title
Oswestry Disability Index 2.0 (ODI)
Description
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.
Time Frame
1st and 4th postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scornavacca
Phone
(51) 9 9216-5580
Ext
+55
Email
fscornavacca@ufcspa.edu.br
Facility Information:
Facility Name
Hospital da Criança Santo Antônio
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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