Virtual Reality for Pediatric Motor Rehabilitation.

Treatment of Balance and Coordination Disorders in the Pediatric Population With the Virtual Reality System Nirvana.

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.

Study Overview

• Status: Recruiting
• Conditions: Coordination and Balance Disturbances
• Intervention / Treatment: Device: NIRVANA

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ELEONORA DIELLA, PHYSIOTHERAPIST; Phone Number: 3286859456; Email: eleonora.diella@lanostrafamiglia.it

Study Locations

• Italy
  • Brindisi, Italy, 72100
    • Recruiting
    • Associazione "La Nostra Famiglia" - Polo Ospedaliero di Neuroriabilitazione, Piazza Di Summa presso ex Complesso Ospedaliero Regionale "A. Di Summa"
    • Contact: ANTONIO TRABACCA, MD; Email: antonio.trabacca@lanostrafamiglia.it
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • Recruiting
      • IRCCS Eugenio Medea
      • Contact: ELEONORA DIELLA, PT; Email: eleonora.diella@lanostrafamiglia.it
  • Treviso
    • Conegliano, Treviso, Italy, 31015
      • Recruiting
      • IRCCS Eugenio Medea
      • Contact: ANDREA MARTINUZZI, MD; Email: andrea.martinuzzi@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: coordination and balance disorders; Subjects will undergo treatment with NIRVANA lasting 45 minutes for 5 sessions per week for 4 weeks combined with equal dose of task-oriented physiotherapy treatment.

Device: NIRVANA; NIRVANA 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stabilometry with force platforms	Evaluation of static balance	T0(pre-training),T1 (after 4 weeks of training)
Gross Motor Function Measure-88 (GMFM-88)	Evaluation of the motricity	T0(pre-training),T1 (after 4 weeks of training)
Pediatric Berg Balance Scale (PBBS)	Functional balance	T0(pre-training),T1 (after 4 weeks of training)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Performance Test (CPT or KCPT)	Test for substained attention	T0(pre-training),T1 (after 4 weeks of training)

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GIP 1061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No