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Clinical Trials/NCT06317519
NCT06317519
Recruiting
Not Applicable

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.

IRCCS Eugenio Medea1 site in 1 country100 target enrollmentApril 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
IRCCS Eugenio Medea
Enrollment
100
Locations
1
Primary Endpoint
6 minute walking test
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
April 12, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Eugenio Medea
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

6 minute walking test

Time Frame: Before and after 4 weeks of treatment

Distance walked over 6 minutes, in meters

Gross Motor Function Measure -total score

Time Frame: Before and after 4 weeks of treatment

Total score on the Gross Motor Function Measure. Greater scores indicate better performance

Study Sites (1)

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