Clinical trial NCT06449495: Virtual Reality for Pediatric Motor Rehabilitation.
Official title: Treatment of Balance and Coordination Disorders in the Pediatric Population With the Virtual Reality System Nirvana.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coordination and Balance Disturbances
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living.

Among the various conditions commonly associated with balance and gait deficits in the pediatric population, neurological diseases represent an important subgroup, as do neurodevelopmental disorders. Children with balance and coordination problems typically have difficulty walking independently and manifest a gait characterized by an enlarged base of support and are generally prone to frequent falls.

Coordination deficits also result in a reduction in the fluidity of functional gestures with a consequent negative impact on quality of life.

Not only that, in the presence of the above-mentioned problems, psycho-motor retardation is also often evident in children, consequently presenting cognitive, relational and learning problems as well.

There are several systems that can be used to treat balance and coordination disorders; in particular, those that use virtual reality systems such as NIRVANA are becoming increasingly popular. This device has been used in subjects with neurological disorders (Stroke, Parkinson's, and Multiple Sclerosis) with good results in both motor and visuocognitive areas. To date there are still few studies of this device in the pediatric setting, although its effectiveness in both autism spectrum disorders and global developmental delays is beginning to be explored.

The primary objective of this post-market clinical investigation is to evaluate the efficacy, in the context of its intended use, 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. Additional objective is to confirm the safety of the device, with the possibility of detecting any emerging risks with respect to expected performance. Secondary objective is to identify guidelines for use in clinical practice of the NIRVANA device with respect to pediatric populations undergoing treatment. Patients undergo a combined rehabilitation treatment consisting of 20 sessions with Nirvana and 20 sessions of physiotherapy (age \>7aa) or psychomotor therapy (age \<=7aa) over four weeks for a total of 40 sessions. The same subjects undergo clinical-functional assessments before and at the end of treatment:

* Stabilometry to assess balance with defined protocol on GAIT (BTS) platforms
* GMFM-88 o PBerg
* Continuous Performance Test (CPT or KCPT) sustained attention assessment test.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* adult
* wheelchair-bound
* major cognitive and behavioural problems.

Primary outcomes:
measure: Stabilometry with force platforms
timeFrame: T0(pre-training),T1 (after 4 weeks of training)
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: T0(pre-training),T1 (after 4 weeks of training)
measure: Pediatric Berg Balance Scale (PBBS)
timeFrame: T0(pre-training),T1 (after 4 weeks of training)
Secondary outcomes:
measure: Continuous Performance Test (CPT or KCPT)
timeFrame: T0(pre-training),T1 (after 4 weeks of training)
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Irccs Eugenio Medea
state: Lecco
city: Conegliano
country: Italy
facility: Irccs Eugenio Medea
state: Treviso
city: Brindisi
country: Italy
facility: Associazione "La Nostra Famiglia" - Polo Ospedaliero di Neuroriabilitazione, Piazza Di Summa presso ex Complesso Ospedaliero Regionale "A. Di Summa"
Study officials:
References: