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Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab)

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06317519
Enrollment
100
Registered
2024-03-19
Start date
2021-04-12
Completion date
2026-04-12
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Cerebral Palsy

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.

Interventions

5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.

DEVICEGait Real-time Analysis Interactive Lab

5 sessions of GRAIL assisted rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.

Sponsors

IRCCS Eugenio Medea
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* Capable of following verbal requests * Gross Motor Function Classification System score I to III

Exclusion criteria

* Severe spasticity * Severe cognitive disability * Severe auditory or visual disability

Design outcomes

Primary

MeasureTime frameDescription
6 minute walking testBefore and after 4 weeks of treatmentDistance walked over 6 minutes, in meters
Gross Motor Function Measure -total scoreBefore and after 4 weeks of treatmentTotal score on the Gross Motor Function Measure. Greater scores indicate better performance

Countries

Italy

Contacts

Primary ContactElena Beretta, MD
elena.beretta@lanostrafamiglia.it031877851

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026