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How Much Virtual Reality Intervention Improve the Balance of Patients with Cerebral Palsy 24 Virtual
Clinical Trial NCT06769178 is an interventional study for Cerebral Palsy and is currently not yet recruiting. Enrollment is planned to begin on 1 June 2025 and continue until the study accrues 24 participants. Led by Yeditepe University, this study is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 10 January 2025.
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 interven...
Show MoreOfficial Title
Effect of Virtual Reality-Based Interventions on Clinical and Neuroplasticity, Brain Functional Resting State Networks in Cerebral Palsy Rehabilitation
Conditions
Cerebral PalsyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- SimayA
NCT ID Number
Start Date (Actual)
2025-06
Last Update Posted
2025-01-10
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
adult cerebral palsy
functional magnetic reasonance imaging
virtual reality
becure systems
balance
resting state functional magnetic reasonance imaging
functional magnetic reasonance imaging
virtual reality
becure systems
balance
resting state functional magnetic reasonance imaging
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSerious 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 droppi...Show More | 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. |
OtherControl 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 mos...Show More | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | up to 8 weeks |
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. | up to 8 weeks |
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). | up to 8 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | up to 8 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
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
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
Yeditepe UniversityStudy Central Contact
Contact: Simay Atıcı, PhD C, +902165780000, [email protected]
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