How Much Virtual Reality Intervention Improve the Balance of Patients with Cerebral Palsy
NCT ID: NCT06769178
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2025-06-30
2026-12-31
Brief Summary
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The main questions it aims to answer are:
Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the clinic? Is there a change in brain functional resting state networks after virtual reality interventions?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Serious Game Group
BecureBalance and WesenseSystems will be used.Games'll be chosen to improve balance and empowerment,and game levels will be adjusted according to the condition of the participants.Balance Adventure is a game that involves transferring weight in 4 directions.At level 1,the goal is to reach the exit by collecting all the stars. At level 3,the goal is to collect stars on a moving surface and move the ball without dropping it.Balance Surf game is played with weight transfer from right to left and forward.The aim of the game is to earn points by steering the surfboard on the screen,collecting stars and gift wrap objects.Sizing Ball and Aerobat games are played by connecting a wearable sensor to the muscle group that the participants want to exercise.By calibrating this sensor, we can assume the angle we want is 0,and when more than the angle we set is made,movement will be revealed in the game.For this,lower extremity muscles will be exercised with these games by wearing a resistance band.
Virtual Reality based
Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games.
Control Group
Participants in the control group will receive a total of 16 sessions of structured NGT-based exercise applications prepared by the researchers.For this, involving balance and strengthening'll be applied, focusing mainly on lower extremity movements. For warm-up exercises, trunk rotation, shoulder rotation, hip rotation and toe-to-toe elevation and descent'll be performed for 10 minutes.Strengthening exercises'll mostly focus on the lower extremity muscles.These exercises'll be practiced for 20 minutes, and the participants'll be given the following exercises while the weight is tied. Each exercise'll be done in 2 sets of 10 repetitions.Balance exercises'll be practiced statically and dynamically for 20 minutes with 2 sets of 10 repetitions.
Virtual Reality based
Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games.
Interventions
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Virtual Reality based
Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
30 Years
ALL
No
Sponsors
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Yeditepe University
OTHER
Responsible Party
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Central Contacts
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References
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You SH, Jang SH, Kim YH, Kwon YH, Barrow I, Hallett M. Cortical reorganization induced by virtual reality therapy in a child with hemiparetic cerebral palsy. Dev Med Child Neurol. 2005 Sep;47(9):628-35.
Wimalasundera N, Stevenson VL. Cerebral palsy. Pract Neurol. 2016 Jun;16(3):184-94. doi: 10.1136/practneurol-2015-001184. Epub 2016 Feb 2.
Warnier N, Lambregts S, Port IV. Effect of Virtual Reality Therapy on Balance and Walking in Children with Cerebral Palsy: A Systematic Review. Dev Neurorehabil. 2020 Nov;23(8):502-518. doi: 10.1080/17518423.2019.1683907. Epub 2019 Nov 1.
Upadhyay J, Ansari MN, Samad A, Sayana A. Dysregulation of multiple signaling pathways: A possible cause of cerebral palsy. Exp Biol Med (Maywood). 2022 May;247(9):779-787. doi: 10.1177/15353702221081022. Epub 2022 Mar 7.
Reyes F, Niedzwecki C, Gaebler-Spira D. Technological Advancements in Cerebral Palsy Rehabilitation. Phys Med Rehabil Clin N Am. 2020 Feb;31(1):117-129. doi: 10.1016/j.pmr.2019.09.002. Epub 2019 Nov 6.
Reid LB, Pagnozzi AM, Fiori S, Boyd RN, Dowson N, Rose SE. Measuring neuroplasticity associated with cerebral palsy rehabilitation: An MRI based power analysis. Int J Dev Neurosci. 2017 May;58:17-25. doi: 10.1016/j.ijdevneu.2017.01.010. Epub 2017 Jan 24.
Papageorgiou E, De Beukelaer N, Simon-Martinez C, Mailleux L, Van Campenhout A, Desloovere K, Ortibus E. Structural Brain Lesions and Gait Pathology in Children With Spastic Cerebral Palsy. Front Hum Neurosci. 2020 Jul 9;14:275. doi: 10.3389/fnhum.2020.00275. eCollection 2020.
Papadelis C, Ahtam B, Feldman HA, AlHilani M, Tamilia E, Nimec D, Snyder B, Ellen Grant P, Im K. Altered White Matter Connectivity Associated with Intergyral Brain Disorganization in Hemiplegic Cerebral Palsy. Neuroscience. 2019 Feb 10;399:146-160. doi: 10.1016/j.neuroscience.2018.12.028. Epub 2018 Dec 26.
Jaatela J, Nurmi T, Vallinoja J, Maenpaa H, Sairanen V, Piitulainen H. Altered corpus callosum structure in adolescents with cerebral palsy: connection to gait and balance. Brain Struct Funct. 2023 Nov;228(8):1901-1915. doi: 10.1007/s00429-023-02692-1. Epub 2023 Aug 24.
Hawe RL, Sukal-Moulton T, Dewald JP. The effect of injury timing on white matter changes in the corpus callosum following unilateral brain injury. Neuroimage Clin. 2013 Aug 8;3:115-22. doi: 10.1016/j.nicl.2013.08.002. eCollection 2013.
Hajebrahimi F, Velioglu HA, Bayraktaroglu Z, Helvaci Yilmaz N, Hanoglu L. Clinical evaluation and resting state fMRI analysis of virtual reality based training in Parkinson's disease through a randomized controlled trial. Sci Rep. 2022 May 16;12(1):8024. doi: 10.1038/s41598-022-12061-3.
Hadzagic-Catibusic F, Avdagic E, Zubcevic S, Uzicanin S. Brain Lesions in Children with Unilateral Spastic Cerebral Palsy. Med Arch. 2017 Feb;71(1):7-11. doi: 10.5455/medarh.2017.71.7-11. Epub 2017 Feb 5.
Erten AB, Tarakci D, Cacan MA. The Effectiveness of Video-Based Game Exercise Therapy Applications in Pes Planus Rehabilitation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 11;12:e51772. doi: 10.2196/51772.
Coskun B, Ay S, Erol Barkana D, Bostanci H, Uzun I, Oktay AB, Tuncel B, Tarakci D. A physiological signal database of children with different special needs for stress recognition. Sci Data. 2023 Jun 14;10(1):382. doi: 10.1038/s41597-023-02272-2.
Other Identifiers
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SimayA
Identifier Type: -
Identifier Source: org_study_id
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