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.

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Acquired Brain Injury
• Intervention / Treatment: Procedure: Physical Rehabilitation; Device: Gait Real-time Analysis Interactive Lab

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Elena Beretta, MD; Phone Number: +39 031877851; Email: elena.beretta@lanostrafamiglia.it

Study Locations

• Italy
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • Recruiting
      • Scientific Institute IRCCS Eugenio Medea
      • Contact: Elena Beretta, MD; Phone Number: +39 031877851; Email: elena.beretta@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged 5 to 20 with either cerebral palsy or acquied brain injury, who can follow verbal orders and are not disabled regarding senses or intellect

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Physical Rehabilitation + GRAIL; Patients in this group receive Physical Rehabilitation and GRAIL treatment	Procedure: Physical Rehabilitation; 5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.; Device: 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	Procedure: Physical Rehabilitation; 5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Estimated): April 12, 2026
• Study Completion (Estimated): April 12, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Cerebral Palsy; Brain Injuries
• Other Study ID Numbers: 09.2020-Oss

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No