Coordination and Balance DisturbancesNCT06449495
Virtual Reality for Pediatric Motor Rehabilitation.
A study testing NIRVANA in people with Coordination and Balance Disturbances, run by IRCCS Eugenio Medea at 3 sites in Italy.
Trial summary
Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living in pediatric population. There are several systems that can be used to treat balance and coordination disorders and those that use virtual reality, such as NIRVANA, are becoming increasingly popular. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Coordination and Balance Disturbances
- What is being tested?
- NIRVANA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Sep 2012to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- balance or coordination disorders of different etiology: tumor, post-traumatic, neurodegenerative, syndromic, congenital, or associated with neurodevelopmental delay. - - - age between 4 and 17 years
- independent ambulation
- ability to understand simple verbal instructions.
Who cannot join
- adult
- wheelchair-bound
- major cognitive and behavioural problems.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Irccs Eugenio Medea
Bosisio Parini, Lecco, 23842
ELEONORA DIELLA, PT, eleonora.diella@lanostrafamiglia.it
- Recruiting
Associazione "La Nostra Famiglia" - Polo Ospedaliero di Neuroriabilitazione, Piazza Di Summa presso ex Complesso Ospedaliero Regionale "A. Di Summa"
Brindisi, 72100
ANTONIO TRABACCA, MD, antonio.trabacca@lanostrafamiglia.it
- Recruiting
Irccs Eugenio Medea
Conegliano, Treviso, 31015
ANDREA MARTINUZZI, MD, andrea.martinuzzi@lanostrafamiglia.it
About this study
Official title: Treatment of Balance and Coordination Disorders in the Pediatric Population With the Virtual Reality System Nirvana.
Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living in pediatric population. There are several systems that can be used to treat balance and coordination disorders and those that use virtual reality, such as NIRVANA, are becoming increasingly popular. The primary objective of this post-market clinical investigation is to evaluate the efficacy of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated.
Read the detailed description
Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living.
Among the various conditions commonly associated with balance and gait deficits in the pediatric population, neurological diseases represent an important subgroup, as do neurodevelopmental disorders. Children with balance and coordination problems typically have difficulty walking independently and manifest a gait characterized by an enlarged base of support and are generally prone to frequent falls.
Coordination deficits also result in a reduction in the fluidity of functional gestures with a consequent negative impact on quality of life.
Not only that, in the presence of the above-mentioned problems, psycho-motor retardation is also often evident in children, consequently presenting cognitive, relational and learning problems as well.
There are several systems that can be used to treat balance and coordination disorders; in particular, those that use virtual reality systems such as NIRVANA are becoming increasingly popular. This device has been used in subjects with neurological disorders (Stroke, Parkinson's, and Multiple Sclerosis) with good results in both motor and visuocognitive areas. To date there are still few studies of this device in the pediatric setting, although its effectiveness in both autism spectrum disorders and global developmental delays is beginning to be explored.
The primary objective of this post-market clinical investigation is to evaluate the efficacy, in the context of its intended use, of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated. Additional objective is to confirm the safety of the device, with the possibility of detecting any emerging risks with respect to expected performance. Secondary objective is to identify guidelines for use in clinical practice of the NIRVANA device with respect to pediatric populations undergoing treatment. Patients undergo a combined rehabilitation treatment consisting of 20 sessions with Nirvana and 20 sessions of physiotherapy (age >7aa) or psychomotor therapy (age <=7aa) over four weeks for a total of 40 sessions. The same subjects undergo clinical-functional assessments before and at the end of treatment:
- Stabilometry to assess balance with defined protocol on GAIT (BTS) platforms
- GMFM-88 o PBerg
- Continuous Performance Test (CPT or KCPT) sustained attention assessment test.
- Conditions
- Coordination and Balance Disturbances
- Being tested
- NIRVANA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRVANADevice
NIRVANA is a medical device using semi-immersive virtual reality for motor and cognitive neuro-rehabilitation.
NIRVANA creates a "sensory room" where the patient can have an immersive and stimulating experience by interacting directly with different realistic scenarios. The system creates different scenarios on the wall or floor, and the patient interacts with the stimuli provided. A motion-analysis device detects the patient's behavior and based on the projected environment provides highly stimulating and rehabilitative audiovisual feedback with full whole-body immersion. The system is preconfigured with a series of exercises, which can be customized based on different types of patients, intervening on the level of difficulty, speed of execution and sensitive area of the projection.
| Study group | Role | What they receive |
|---|---|---|
| coordination and balance disorders | Experimental | Subjects will undergo treatment with NIRVANA lasting 45 minutes for 5 sessions per week for 4 weeks combined with equal dose of task-oriented physiotherapy treatment. Receives: Device: NIRVANA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilometry with force platforms
Evaluation of static balance
Measured: T0(pre-training),T1 (after 4 weeks of training)
Gross Motor Function Measure-88 (GMFM-88)
Evaluation of the motricity
Measured: T0(pre-training),T1 (after 4 weeks of training)
Pediatric Berg Balance Scale (PBBS)
Functional balance
Measured: T0(pre-training),T1 (after 4 weeks of training)
Secondary outcomes (1)
Continuous Performance Test (CPT or KCPT)
Test for substained attention
Measured: T0(pre-training),T1 (after 4 weeks of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Sep 2012
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coordination and Balance DisturbancesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT06449495
- Sponsor's protocol ID
- GIP 1061
- Status last verified
- Jul 2024
- First submitted
- 17 Oct 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Balance and Coordination Disorders in the Pediatric Population With the Virtual Reality System Nirvana.
- ClinicalTrials.gov ID
- NCT06449495
- Acronym / sponsor ID
- GIP 1061
- Conditions
- Coordination and Balance Disturbances
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jun 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.
Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living in pediatric population. There are several systems that can be used to treat balance and coordination disorders and those that use virtual reality, such as NIRVANA, are becoming increasingly popular. The primary objective of this post-market clinical investigation is to evaluate the efficacy of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated.
Detailed description
Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living.
Among the various conditions commonly associated with balance and gait deficits in the pediatric population, neurological diseases represent an important subgroup, as do neurodevelopmental disorders. Children with balance and coordination problems typically have difficulty walking independently and manifest a gait characterized by an enlarged base of support and are generally prone to frequent falls.
Coordination deficits also result in a reduction in the fluidity of functional gestures with a consequent negative impact on quality of life.
Not only that, in the presence of the above-mentioned problems, psycho-motor retardation is also often evident in children, consequently presenting cognitive, relational and learning problems as well.
There are several systems that can be used to treat balance and coordination disorders; in particular, those that use virtual reality systems such as NIRVANA are becoming increasingly popular. This device has been used in subjects with neurological disorders (Stroke, Parkinson's, and Multiple Sclerosis) with good results in both motor and visuocognitive areas. To date there are still few studies of this device in the pediatric setting, although its effectiveness in both autism spectrum disorders and global developmental delays is beginning to be explored.
The primary objective of this post-market clinical investigation is to evaluate the efficacy, in the context of its intended use, of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated. Additional objective is to confirm the safety of the device, with the possibility of detecting any emerging risks with respect to expected performance. Secondary objective is to identify guidelines for use in clinical practice of the NIRVANA device with respect to pediatric populations undergoing treatment. Patients undergo a combined rehabilitation treatment consisting of 20 sessions with Nirvana and 20 sessions of physiotherapy (age >7aa) or psychomotor therapy (age <=7aa) over four weeks for a total of 40 sessions. The same subjects undergo clinical-functional assessments before and at the end of treatment:
- Stabilometry to assess balance with defined protocol on GAIT (BTS) platforms
- GMFM-88 o PBerg
- Continuous Performance Test (CPT or KCPT) sustained attention assessment test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coordination and balance disorders | Experimental | Device: NIRVANASubjects will undergo treatment with NIRVANA lasting 45 minutes for 5 sessions per week for 4 weeks combined with equal dose of task-oriented physiotherapy treatment. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- balance or coordination disorders of different etiology: tumor, post-traumatic, neurodegenerative, syndromic, congenital, or associated with neurodevelopmental delay. - - - age between 4 and 17 years
- independent ambulation
- ability to understand simple verbal instructions.
Key exclusion criteria (3 listed)
- adult
- wheelchair-bound
- major cognitive and behavioural problems.
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 |
|---|---|---|
| NIRVANANIRVANA is a medical device using semi-immersive virtual reality for motor and cognitive neuro-rehabilitation. NIRVANA creates a "sensory room" where the patient can have an immersive and stimulating experience by interacting directly with different realistic scenarios. The system creates different scenarios on the wall or floor, and the patient interacts with the stimuli provided. A motion-analysis device detects the patient's behavior and based on the projected environment provides highly stimulating and rehabilitative audiovisual feedback with full whole-body immersion. The system is preconfigured with a series of exercises, which can be customized based on different types of patients, intervening on the level of difficulty, speed of execution and sensitive area of the projection. | Device | coordination and balance disorders |
Primary outcome
Stabilometry with force platforms
Time frame: T0(pre-training),T1 (after 4 weeks of training)
Evaluation of static balance
Gross Motor Function Measure-88 (GMFM-88)
Time frame: T0(pre-training),T1 (after 4 weeks of training)
Evaluation of the motricity
Pediatric Berg Balance Scale (PBBS)
Time frame: T0(pre-training),T1 (after 4 weeks of training)
Functional balance
1 secondary outcome
Continuous Performance Test (CPT or KCPT)
Time frame: T0(pre-training),T1 (after 4 weeks of training)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRVANA in people with Coordination and Balance Disturbances, run by IRCCS Eugenio Medea at 3 sites 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 3 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: looking for participants now, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELEONORA DIELLA, PHYSIOTHERAPIST (3286859456, eleonora.diella@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stabilometry with force platforms (time frame: T0(pre-training),T1 (after 4 weeks of training)). The study lists 3 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 9 Jul 2024.