Virtual Reality for Pediatric Motor Rehabilitation.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorIRCCS Eugenio Medea
About this trial
Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living in pediatric population. There are several systems that can be used to treat balance and coordination disorders and those that use virtual reality, such as NIRVANA, are becoming increasingly popular. The primary objective of this post-market clinical investigation is to evaluate the efficacy of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
balance or coordination disorders of different etiology: tumor, post-traumatic, neurodegenerative, syndromic, congenital, or associated with neurodevelopmental delay. - - - age between 4 and 17 years
independent ambulation
ability to understand simple verbal instructions.
Disqualifiers
adult
wheelchair-bound
major cognitive and behavioural problems.
Trial design
Design model
Single group
Treatments tested in this trial
NIRVANA
DeviceNIRVANA is a medical device using semi-immersive virtual reality for motor and cognitive neuro-rehabilitation. NIRVANA creates a "sensory room" where the patient can have an immersive and stimulating experience by interacting directly with different realistic scenarios. The system creates different scenarios on the wall or floor, and the patient interacts with the stimuli provided. A motion-analysis device detects the patient's behavior and based on the projected environment provides highly stimulating and rehabilitative audiovisual feedback with full whole-body immersion. The system is preconfigured with a series of exercises, which can be customized based on different types of patients, intervening on the level of difficulty, speed of execution and sensitive area of the projection.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: coordination and balance disordersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stabilometry with force platforms
Evaluation of static balance
Time frame
T0(pre-training),T1 (after 4 weeks of training)2
Gross Motor Function Measure-88 (GMFM-88)
Evaluation of the motricity
Time frame
T0(pre-training),T1 (after 4 weeks of training)3
Pediatric Berg Balance Scale (PBBS)
Functional balance
Time frame
T0(pre-training),T1 (after 4 weeks of training)Secondary outcomes
1
Continuous Performance Test (CPT or KCPT)
Test for substained attention
Time frame
T0(pre-training),T1 (after 4 weeks of training)Sponsors and contacts
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Source ClinicalTrials.gov