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

Effect of Virtual Reality-Based Interventions on Clinical and Neuroplasticity, Brain Functional Resting State Networks in Cerebral Palsy Rehabilitation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06769178
Enrollment
24
Registered
2025-01-10
Start date
2026-01-23
Completion date
2027-07-01
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

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

Brief 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?

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.

Sponsors

Yeditepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle Strength Assessmentup to 8 weeksMuscle 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.
Timed Up and Go Test (TUG)up to 8 weeksTUG 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.
Berg Balance Scale (BBS)up to 8 weeksThe 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).

Secondary

MeasureTime frameDescription
fMRI scanup to 8 weeksHigh-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

Countries

Turkey (Türkiye)

Contacts

CONTACTSimay Atıcı, PhD C
simayaticii@hotmail.com+902165780000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026