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

Recruiting

• Conditions: Cerebral Palsy; Acquired Brain Injury
• Interventions: Procedure: Physical Rehabilitation; Device: Gait Real-time Analysis Interactive Lab

• Registration Number: NCT06317519
• Lead Sponsor: IRCCS Eugenio Medea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-12
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2026-04-12
• Study Completion: 2026-04-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physical Rehabilitation + GRAIL	Gait Real-time Analysis Interactive Lab	Patients in this group receive Physical Rehabilitation and GRAIL treatment
Physical Rehabilitation	Physical Rehabilitation	Patients in this group receive Physical Rehabilitation not GRAIL treatment
Physical Rehabilitation + GRAIL	Physical Rehabilitation	Patients in this group receive Physical Rehabilitation and GRAIL treatment

Primary Outcome Measures

Name	Time	Method
6 minute walking test	Before and after 4 weeks of treatment	Distance walked over 6 minutes, in meters
Gross Motor Function Measure -total score	Before and after 4 weeks of treatment	Total score on the Gross Motor Function Measure. Greater scores indicate better performance

Trial Locations

Locations (1)

Scientific Institute IRCCS Eugenio Medea; 🇮🇹 Bosisio Parini, Lecco, Italy