Virtual Reality for Pediatric Motor Rehabilitation.

NCT06449495 | Recruiting

• 1 other identifier: GIP 1061
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Coordination and Balance Disturbances

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Continuous Performance Test (CPT or KCPT)

  T0(pre-training),T1 (after 4 weeks of training)

Study Arms (1)

coordination and balance disorders

EXPERIMENTAL

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

Interventions

NIRVANA DEVICE

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.

coordination and balance disorders

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (3)

Irccs Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

Irccs Eugenio Medea

Conegliano, Treviso, 31015, Italy

RECRUITING

Associazione "La Nostra Famiglia" - Polo Ospedaliero di Neuroriabilitazione, Piazza Di Summa presso ex Complesso Ospedaliero Regionale "A. Di Summa"

Brindisi, 72100, Italy

RECRUITING

Central Study Contacts

ELEONORA DIELLA, PHYSIOTHERAPIST

CONTACT

3286859456; eleonora.diella@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: June 10, 2024
• Study Start: September 1, 2012
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

IT (3)