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

NCT ID: NCT06317519

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-12

Study Completion Date

2026-04-12

Brief Summary

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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

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Conditions

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Acquired Brain Injury Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Physical Rehabilitation + GRAIL

Patients in this group receive Physical Rehabilitation and GRAIL treatment

Physical Rehabilitation

Intervention Type PROCEDURE

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

Gait Real-time Analysis Interactive Lab

Intervention Type DEVICE

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

Physical Rehabilitation

Intervention Type PROCEDURE

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

Interventions

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Physical Rehabilitation

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

Intervention Type PROCEDURE

Gait Real-time Analysis Interactive Lab

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, Lecco, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Beretta, MD

Role: CONTACT

031877851 ext. +39

Facility Contacts

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Elena Beretta, MD

Role: primary

031877851 ext. +39

Other Identifiers

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09.2020-Oss

Identifier Type: -

Identifier Source: org_study_id

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