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

Cerebral Palsy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317519
• Other study ID #: 09.2020-Oss
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: April 12, 2026

Study information

• Verified date: March 2024
• Source: IRCCS Eugenio Medea
• Contact: Elena Beretta, MD
• Phone: 031877851
• Email: elena.beretta[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 12, 2026
• Est. primary completion date: April 12, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS Eugenio Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walking test	Distance walked over 6 minutes, in meters	Before and after 4 weeks of treatment
Primary	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