ClinicalTrials.gg
RecruitingNCT06769178Updated Jul 30, 2026

How Much Virtual Reality Intervention Improve the Balance of Patients With Cerebral Palsy

An interventional study of Virtual Reality based in Cerebral Palsy, sponsored by Yeditepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Yeditepe University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation.

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?

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • adult cerebral palsy
  • functional magnetic reasonance imaging
  • virtual reality
  • becure systems
  • balance
  • resting state functional magnetic reasonance imaging
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 24 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Yeditepe University is the lead sponsor of 131 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Being diagnosed with unilateral spastic type cerebral palsy (hemiplegic type) / Being between the ages of 18-30 / Being able to walk independently (GMFCS I-II) / Not having Botox application in the last six months / Not using any medication that will affect the study process

Exclusion criteria

Exclusion Criteria:

Having a history of epileptic attacks / Having >2 spasticity in any joint according to the modified Ashworth scale / Having severe depression according to the Beck Depression Inventory /Having hearing-vision problems

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Virtual Reality based

  • Other
    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.

    Other: Virtual Reality based

Interventions

  • OtherVirtual 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.

    Also known as: Neurodevelopmental based

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What researchers measure

Primary outcomes

  1. Muscle Strength Assessment

    Muscle strength is an important component of health. Muscle weakness is seen in the presence of neurologicaldiseases and therefore muscle strength measurement is important for general health assessment. The most common equipment or methods that provide quantitative measurements of strength, such as isokinetic and portable dynamometers, have been shown to provide valid and reliable measurements. The muscle strengths of the participants in the lower extremity (hip flexor, extensor, abductor and adductor, knee flexor and extensor, ankle dorsi-plantar flexor) muscle groups will be measured with a handheld dynamometer.

    Time frame: up to 8 weeks

  2. Timed Up and Go Test (TUG)

    TUG is a rapid test used in clinic as an outcome measure to assess functional mobility as well as static and dynamic balance. It's based on the length of time which takes for an individual to get up from a chair, walk 3 meters at a comfortable (or fastest) pace, turn (or touch the wall), walk to chair and sit down again.

    Time frame: up to 8 weeks

  3. Berg Balance Scale (BBS)

    The BBS, developed by Berg et al (1995) and used in the assessment of balance, is a four-point scale that rates patients' balance from easy to difficult (0: cannot do, 4: does independently). During the test consisting of 14 items, steps, rulers, stopwatches and chairs are used. The test evaluates postural control and fall risk. The maximum total score is 56 points. 0-20: high fall risk, 21-40: moderate fall risk, 41-56: low fall risk. The Turkish validity and reliability of the scale was made by Şahin et al (2008).

    Time frame: up to 8 weeks

Secondary outcomes

  1. fMRI scan

    High-resolution (1 x 1 x 1 mm isotropic) sagittal 190 slices will be acquired with a T1-weighted imaging sequence (TR/TE: 7.7/3.7 ms;, FA: 8°; FOV: 256 x 256). Functional resting state data will be acquired with a single-shot echo planar imaging (EPI) sequence of 300 dynamic acquisitions consisting of 35 slices of 4 mm thickness (TR/TE: 2230/30 ms, FA: 77°; matrix: 80x80) and will last approximately 11 minutes. Magnetic field maps will be recorded in order to correct signal distortions caused by tissue inhomogeneities in the magnetic field during the analysis phase before functional acquisition. Participants will be asked to fix their gaze on a point by keeping their eyes open during functional acquisitions. Participants will be informed that they can close their eyes and rest during the other stages of the acquisitions. fMRI acquisitions will be completed in approximately 30 minutes, including the preparation stages. The MRI acquisition sequences will be as follows: Survey, Resting S

    Time frame: up to 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 16138671 ↗
  • Wimalasundera N, Stevenson VL. Cerebral palsy. Pract Neurol. 2016 Jun;16(3):184-94. doi: 10.1136/practneurol-2015-001184. Epub 2016 Feb 2. PubMed 26837375 ↗
  • 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. PubMed 31674852 ↗
  • 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. PubMed 35253451 ↗
  • 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. PubMed 31760985 ↗
  • 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. PubMed 28130065 ↗
  • 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. PubMed 32733223 ↗
  • 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. PubMed 30593919 ↗
  • 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. PubMed 37615759 ↗
  • 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. PubMed 24179855 ↗
  • 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. PubMed 35577874 ↗
  • 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. PubMed 28428665 ↗
  • 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. PubMed 37695657 ↗
  • 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. PubMed 37316526 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 11 months is close to that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2024
First posted
Jan 10, 2025
StartActual
Jan 23, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Jul 2027
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06769178
Responsible party
Sponsor
First posted
Jan 10, 2025
Start date
Jan 23, 2026
Primary completion
Dec 2026 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jul 30, 2026

Study contacts

Simay Atıcı, PhD C
Contact
simayaticii@hotmail.com
+902165780000 ext. 3037

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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