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

NCT05950100 | Unknown DMC

• 1 other identifier: 5.930.492
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic

Keywords

Virtual Reality; Postural Balance; Scoliosis; Pediatrics; Postoperative Period; Rehabilitation; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Visual Analog Scale (VAS)

  until the 4th postoperative day

• Length of stay

  Baseline

• Sociodemographic questionnaire

  1st postoperative day

• Revised Scoliosis Research Society-22 (SRS-22r)

  1st and 4th postoperative day

• Oswestry Disability Index 2.0 (ODI)

  1st and 4th postoperative day

Study Arms (2)

Control group

NO INTERVENTION

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

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

Interventions

Virtual reality group DEVICE

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.

Also known as: GRV

Virtual reality group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• moderate to severe cognitive impairment;
• difficulty understanding simple orders;
• other physical conditions that limit trunk movements, orthostasis and/or cause pain;
• medical contraindication.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (1)

Hospital da Criança Santo Antônio

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Related Publications (23)

• Pasha S, Baldwin K. Are we simplifying balance evaluation in adolescent idiopathic scoliosis? Clin Biomech (Bristol). 2018 Jan;51:91-98. doi: 10.1016/j.clinbiomech.2017.11.011. Epub 2017 Nov 29.

  PMID: 29277028 BACKGROUND

• Silva KCVD, Pimentel BN, Santos Filha VAVD. Quantitative and qualitative assessment of body balance in active elderly women and their relation to health in general. Codas. 2020 Nov 13;32(6):e20180246. doi: 10.1590/2317-1782/20202018246. eCollection 2020. English, Portuguese.

  PMID: 33206770 BACKGROUND

• Jha KK, Karunanithi GB, Sahana A, Karthikbabu S. Randomised trial of virtual reality gaming and physiotherapy on balance, gross motor performance and daily functions among children with bilateral spastic cerebral palsy. Somatosens Mot Res. 2021 Jun;38(2):117-126. doi: 10.1080/08990220.2021.1876016. Epub 2021 Mar 3.

  PMID: 33655813 BACKGROUND

• Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.

  PMID: 28109566 BACKGROUND

• Beani E, Filogna S, Martini G, Barzacchi V, Ferrari A, Guidi E, Menici V, Cioni G, Sgandurra G. Application of Virtual Reality Rehabilitation System for the assessment of postural control while standing in typical children and peers with neurodevelopmental disorders. Gait Posture. 2022 Feb;92:364-370. doi: 10.1016/j.gaitpost.2021.12.008. Epub 2021 Dec 10.

  PMID: 34923256 BACKGROUND

• Cheng JC, Castelein RM, Chu WC, Danielsson AJ, Dobbs MB, Grivas TB, Gurnett CA, Luk KD, Moreau A, Newton PO, Stokes IA, Weinstein SL, Burwell RG. Adolescent idiopathic scoliosis. Nat Rev Dis Primers. 2015 Sep 24;1:15030. doi: 10.1038/nrdp.2015.30.

  PMID: 27188385 BACKGROUND

• Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

  PMID: 29435499 BACKGROUND

• Akbar M, Almansour H, Lafage R, Diebo BG, Wiedenhofer B, Schwab F, Lafage V, Pepke W. Sagittal alignment of the cervical spine in the setting of adolescent idiopathic scoliosis. J Neurosurg Spine. 2018 Nov 1;29(5):506-514. doi: 10.3171/2018.3.SPINE171263. Epub 2018 Aug 24.

  PMID: 30141764 BACKGROUND

• Marinho, M.F.; Paz, J.V.C. da Qualidade de vida após tratamento cirúrgico para escoliose idiopática do adolescente: revisão sistemática da literatura. Research, Society and Development, v. 11, n. 4, p. e21211427014, 2022.

  BACKGROUND

• Santiago, H.A.R. A influência da escoliose idiopática do adolescente e do seu tratamento cirúrgico sobre o equilíbrio semi- estático. Teses.Usp.Br, v. 126, n. 16, p. 2016, 2011.

  BACKGROUND

• Latorre, B.P.; Carvalho, M.T.X.; et al. A realidade virtual melhora o equilíbrio e o desempenho motor de uma criança com paralisia cerebral: relato de caso. Saúde (Santa Maria), v. 46, n. 2, p. 1-8, 2020.

  BACKGROUND

• Aroeira RMC, Leal JS, Pertence AEM, Casas EBL, Greco M. Non-ionizing method of screening adolescent idiopathic scoliosis in schoolchildren. Cien Saude Colet. 2019 Feb;24(2):523-534. doi: 10.1590/1413-81232018242.12882017. English, Portuguese.

  PMID: 30726384 BACKGROUND

• Herdea A, Dragomirescu MC, Ulici A, Lungu CN, Charkaoui A. Controlling the Progression of Curvature in Children and Adolescent Idiopathic Scoliosis Following the Administration of Melatonin, Calcium, and Vitamin D. Children (Basel). 2022 May 21;9(5):758. doi: 10.3390/children9050758.

  PMID: 35626935 BACKGROUND

• Herdea A, Stancu TA, Ulici A, Lungu CN, Dragomirescu MC, Charkaoui A. Quality of Life Evaluation Using SRS-30 Score for Operated Children and Adolescent Idiopathic Scoliosis. Medicina (Kaunas). 2022 May 18;58(5):674. doi: 10.3390/medicina58050674.

  PMID: 35630090 BACKGROUND

• Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.

  PMID: 27625122 BACKGROUND

• Xavier, M.J.; Rodrigues, N.M.N.M.; et al. Realidade virtual na reabilitação da paralisia cerebral: Um estudo de caso. Brazilian Journal of Development, v. 6, n. 7, p. 47002-47011, 2020.

  BACKGROUND

• Souza Filho, B.A.B. de; Tritany, É.F. Realidade virtual imersiva nos Cuidados Paliativos: perspectivas para a Reabilitação Total. Cadernos Brasileiros de Terapia Ocupacional, v. 30, p. 1-13, 2022.

  BACKGROUND

• Nicolini-Panisson RD, Donadio MV. Timed "Up & Go" test in children and adolescents. Rev Paul Pediatr. 2013 Sep;31(3):377-83. doi: 10.1590/S0103-05822013000300016.

  PMID: 24142322 BACKGROUND

• Silva, B.C.; Torre, C.R.M.A. De; et al. Compensações realizadas por crianças com paralisia cerebral espástica durante o levantar da cadeira. Revista Neurociências, v. 29, p. 1-20, 2021.

  BACKGROUND

• Melo RS, Marinho SEDS, Freire MEA, Souza RA, Damasceno HAM, Raposo MCF. Static and dynamic balance of children and adolescents with sensorineural hearing loss. Einstein (Sao Paulo). 2017 Jul-Sep;15(3):262-268. doi: 10.1590/S1679-45082017AO3976.

  PMID: 29091145 BACKGROUND

• Ries LG, Michaelsen SM, Soares PS, Monteiro VC, Allegretti KM. Cross-cultural adaptation and reliability analysis of the Brazilian version of Pediatric Balance Scale (PBS). Rev Bras Fisioter. 2012 Jun;16(3):205-15. doi: 10.1590/s1413-35552012005000026. Epub 2012 Jun 14. English, Portuguese.

  PMID: 22699691 BACKGROUND

• Sá, C. dos S.C. de; Fávero, F.M.; et al. Versão brasileira da Segmental Assessment of Trunk Control (SATCo). Fisioterapia e Pesquisa, v. 24, n. 1, p. 89-99, 2017.

  BACKGROUND

• CRUZ, D.M.C. da; PARKINSON, S.; et al. Correlações entre a Participação Ocupacional, Independência e Cognição em Adultos com Deficiência Física. Revista Brasileira de Educação Especial, v. 27, p. 105-118, 2021.

  BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Scornavacca

CONTACT

(51) 9 9216-5580; fscornavacca@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant teacher of the Pediatrics Department

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 18, 2023
• Study Start: June 17, 2023
• Primary Completion: December 29, 2023
• Study Completion: June 30, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

BR (1)