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

NCT06317519 | Recruiting

• 1 other identifier: 09.2020-Oss
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Physical Rehabilitation + GRAIL

Patients in this group receive Physical Rehabilitation and GRAIL treatment

Procedure: Physical Rehabilitation; Device: Gait Real-time Analysis Interactive Lab

Physical Rehabilitation

Patients in this group receive Physical Rehabilitation not GRAIL treatment

Procedure: Physical Rehabilitation

Interventions

Physical Rehabilitation PROCEDURE

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

Physical Rehabilitation; Physical Rehabilitation + GRAIL

Gait Real-time Analysis Interactive Lab DEVICE

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

Physical Rehabilitation + GRAIL

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Severe spasticity
• Severe cognitive disability
• Severe auditory or visual disability

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic

Central Study Contacts

Elena Beretta, MD

CONTACT

031877851; elena.beretta@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: April 12, 2021
• Primary Completion: April 12, 2026
• Study Completion: April 12, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)