Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449495
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-10-17
Brief Title:
Virtual Reality for Pediatric Motor Rehabilitation
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Treatment of Balance and Coordination Disorders in the Pediatric Population With the Virtual Reality System Nirvana
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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
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 Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None