Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab)
NCT ID: NCT06317519
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2021-04-12
2026-04-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Physical Rehabilitation + GRAIL
Patients in this group receive Physical Rehabilitation and GRAIL treatment
Physical Rehabilitation
5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.
Gait Real-time Analysis Interactive Lab
5 sessions of GRAIL assisted rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.
Physical Rehabilitation
Patients in this group receive Physical Rehabilitation not GRAIL treatment
Physical Rehabilitation
5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.
Interventions
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Physical Rehabilitation
5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.
Gait Real-time Analysis Interactive Lab
5 sessions of GRAIL assisted rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Gross Motor Function Classification System score I to III
Exclusion Criteria
* Severe cognitive disability
* Severe auditory or visual disability
5 Years
20 Years
ALL
No
Sponsors
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IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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Scientific Institute IRCCS Eugenio Medea
Bosisio Parini, Lecco, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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09.2020-Oss
Identifier Type: -
Identifier Source: org_study_id
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