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Clinical Trials/NCT06769178
NCT06769178
Not Yet Recruiting
N/A

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

Yeditepe University0 sites24 target enrollmentJune 2025
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Yeditepe University
Enrollment
24
Primary Endpoint
Muscle Strength Assessment
Status
Not Yet Recruiting
Last Updated
last year

Overview

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?

Registry
clinicaltrials.gov
Start Date
June 2025
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Muscle Strength Assessment

Time Frame: up to 8 weeks

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.

Timed Up and Go Test (TUG)

Time Frame: up to 8 weeks

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.

Berg Balance Scale (BBS)

Time Frame: up to 8 weeks

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).

Secondary Outcomes

  • fMRI scan(up to 8 weeks)

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