Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317519
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-12
Brief Title:
Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL Gait Real-time Analysis Interactive Lab
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL Gait Real-time Analysis Interactive Lab in Children and Adolescents Affected by Congenital and Acquired Brain Injury and Determine Any Secondary Effects
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Gait pattern difficulties balance and coordination deficits often characterize patients with congenital and acquired neuromotor disorders and have a significant impact on the quality of life of these subjects There are various treatments used and in recent years the advent of advanced technologies in rehabilitation and in particular devices based on virtual reality has opened up new possibilities in rehabilitation Virtual reality is a promising strategy that incorporates many principles crucial to motor learning such as high-intensity repetitive goal-oriented tasks enhanced synchronized sensory signals and active participation The virtual environment is also suitable for personalized treatment based on the needs of the individual patient
The GRAIL Gait Real-time Analysis Interactive Lab is a device that integrates immersive virtual reality with an instrumented treadmill and a motion capture system which can be used with both rehabilitation and evaluation goals To date there are still few studies of this device in the pediatric field
The objective of the study is to verify the performance in clinical practice of the immersive virtual reality platform GRAIL and determine any secondary effects by evaluating whether they entail acceptable risks compared to the expected performances following the protocol defined at the IRCCS Medea by Bosisio Parini in children and adolescents with congenital and acquired neuromotor pathology
Patients suffering from acquired and congenital brain injuries undergo a combined rehabilitation treatment consisting of 20 sessions with GRAIL and 20 physiotherapy sessions in four weeks The same subjects undergo evaluations before and at the end of the treatment
The study is prospective and involves the verification of performance through clinical and instrumental evaluations in the population of subjects treated with the GRAIL device at the IRCCS Medea-Bosisio Parini
The GRAIL Gait Real-time Analysis Interactive Lab is a device that integrates immersive virtual reality with an instrumented treadmill and a motion capture system which can be used with both rehabilitation and evaluation goals To date there are still few studies of this device in the pediatric field
The objective of the study is to verify the performance in clinical practice of the immersive virtual reality platform GRAIL and determine any secondary effects by evaluating whether they entail acceptable risks compared to the expected performances following the protocol defined at the IRCCS Medea by Bosisio Parini in children and adolescents with congenital and acquired neuromotor pathology
Patients suffering from acquired and congenital brain injuries undergo a combined rehabilitation treatment consisting of 20 sessions with GRAIL and 20 physiotherapy sessions in four weeks The same subjects undergo evaluations before and at the end of the treatment
The study is prospective and involves the verification of performance through clinical and instrumental evaluations in the population of subjects treated with the GRAIL device at the IRCCS Medea-Bosisio Parini
Detailed Description:
None
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