Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05950100
Status:
RECRUITING
Last Update Posted:
2023-07-18
First Post:
2023-07-05
Brief Title:
Impact of Virtual Reality on the Postoperative Balance of Adolescents With Idiopathic Scoliosis
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Federal University of Health Science of Porto Alegre
Study Overview
Official Title:
Impact of Virtual Reality on the Postoperative Balance of Adolescents With Idiopathic Scoliosis
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 institutions 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 worlds 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 users 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 patients 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 Childrens 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 andor 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 005 and the statistical program for data analysis will be SPSS for Windows version 25
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None