Acquired Brain InjuryNCT06317519
Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab)
An observational study of Acquired Brain Injury and Cerebral Palsy, run by IRCCS Eugenio Medea at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Acquired Brain Injury, Cerebral Palsy
- What is being tested?
- Physical Rehabilitation and Gait Real-time Analysis Interactive Lab
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2021to 12 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Capable of following verbal requests
- Gross Motor Function Classification System score I to III
Who cannot join
- Severe spasticity
- Severe cognitive disability
- Severe auditory or visual disability
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute IRCCS Eugenio Medea
Bosisio Parini, Lecco, 23842
Elena Beretta, MD, 031877851 ext. +39, elena.beretta@lanostrafamiglia.it
About this study
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.
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.
Read more
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
- Being tested
- Physical Rehabilitation, Gait Real-time Analysis Interactive Lab
- Medical subject headings
- Brain Injuries, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical RehabilitationProcedure or surgery
5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.
Gait Real-time Analysis Interactive LabDevice
5 sessions of GRAIL assisted rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physical Rehabilitation + GRAIL | Patients in this group receive Physical Rehabilitation and GRAIL treatment Receives: Procedure: Physical Rehabilitation; Device: Gait Real-time Analysis Interactive Lab | |
| Physical Rehabilitation | Patients in this group receive Physical Rehabilitation not GRAIL treatment Receives: Procedure: Physical Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking test
Distance walked over 6 minutes, in meters
Measured: 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
Measured: Before and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start12 Apr 2021
- Primary completion12 Apr 2026 (estimated)
- Study completion12 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317519
- Sponsor's protocol ID
- 09.2020-Oss
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06317519
- Acronym / sponsor ID
- 09.2020-Oss
- Conditions
- Acquired Brain Injury, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 12 Apr 2026 (estimated)
- Study completion
- 12 Apr 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Rehabilitation + GRAIL | – | Procedure: Physical Rehabilitation, Device: Gait Real-time Analysis Interactive LabPatients in this group receive Physical Rehabilitation and GRAIL treatment |
| Physical Rehabilitation | – | Procedure: Physical RehabilitationPatients in this group receive Physical Rehabilitation not GRAIL treatment |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- Capable of following verbal requests
- Gross Motor Function Classification System score I to III
Key exclusion criteria (3 listed)
- Severe spasticity
- Severe cognitive disability
- Severe auditory or visual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Rehabilitation5 sessions of physical rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks. | Procedure or surgery | Physical Rehabilitation, Physical Rehabilitation + GRAIL |
| Gait Real-time Analysis Interactive Lab5 sessions of GRAIL assisted rehabilitation per week. Each session lasting 45 minutes. Overall 20 sessions = 4 weeks. | Device | Physical Rehabilitation + GRAIL |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Brain Injury and Cerebral Palsy, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Beretta, MD (031877851 ext. +39, elena.beretta@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walking test (time frame: Before and after 4 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.