Autism Spectrum DisorderBRAVENCT04276571
EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality
A study testing exergames with GRAIL virtual immersive reality environment in people with Autism Spectrum Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The general objective of this project is to investigate the possible efficacy of a training based on proprioceptive and visual feedback carried out with the GRAIL (Motekforce Link) virtual reality environment on postural control and balance skills of school-aged children with clinical diagnosis of ASD. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- exergames with GRAIL virtual immersive reality environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2019to 31 Dec 2022
- Phase
- Interventional
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a clinical diagnosis of ASD
- All participants were required to have estimated FSIQ of 80 or above
Who cannot join
- using any stimulant or non-stimulant medication that affects the central nervous system
- having an identified genetic disorder
- having vision or hearing problems
- suffering from chronic or acute medical illness
- presence of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
The general objective of this project is to investigate the possible efficacy of a training based on proprioceptive and visual feedback carried out with the GRAIL (Motekforce Link) virtual reality environment on postural control and balance skills of school-aged children with clinical diagnosis of ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- exergames with GRAIL virtual immersive reality environment
- Keywords
- motor abilities
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exergames with GRAIL virtual immersive reality environmentDevice
The participants will perform exergames on GRAIL immersive virtual reality to improve balance (e.g. load shifts, exercises with adaptations to motor perturbations). GRAIL can provide proprioceptive and visual feedback to participants.
| Study group | Role | What they receive |
|---|---|---|
| GRAIL | Experimental | Not described Receives: Device: exergames with GRAIL virtual immersive reality environment |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
experimental balance assessment
Balance assessment through the evaluation (with both open and closed eyes) of the center of pression using the GRAIL platform
Measured: approximately 6 weeks after starting the intervention
Movement Assessment Battery for Children 2 (MABC2) (Henderson et al., 2007).
The MABC2 consists of eight subtests that evaluate three components of motor proficiency: manual dexterity, ball skills, and static and dynamic balance. For the MABC2, higher scores are indicative of better motor performance.
Measured: approximately 6 weeks after starting the intervention
Secondary outcomes (4)
Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007).
The DCDQ is a 15-item questionnaire that investigates gross and fine motor skill impairments. The DCDQ yields a raw total score (score range 15-75); higher scores indicate better motor functioning as rated by the parents.
Measured: approximately 6 weeks after starting the intervention
assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill the dominant side at toe-off
assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill
Measured: approximately 6 weeks after starting the intervention
assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis
assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis
Measured: approximately 6 weeks after starting the intervention
evaluation of gait features using the GRAIL (Motekforce Link)
evaluation of gait features using the GRAIL (Motekforce Link)
Measured: approximately 6 weeks after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start18 Oct 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276571
- Sponsor's protocol ID
- GIP-679
- Acronym
- BRAVE
- Status last verified
- Sep 2023
- First submitted
- 18 Feb 2020
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.
PubMed 30618953Falivene A, Scaccabarozzi G, Busti Ceccarelli S, Molteni M, Klingels K, Verbecque E, Storm FA, Biffi E, Crippa A. Virtual Reality-Based Postural Balance Training in Autistic Children: A Pilot Randomized Controlled Trial. J Clin Med. 2025 Aug 8;14(16):5616. doi: 10.3390/jcm14165616.
PubMed 40869441
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality
- ClinicalTrials.gov ID
- NCT04276571
- Acronym / sponsor ID
- BRAVE / GIP-679
- Conditions
- Autism Spectrum Disorder
- Keywords
- motor abilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Feb 2020 (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.
The general objective of this project is to investigate the possible efficacy of a training based on proprioceptive and visual feedback carried out with the GRAIL (Motekforce Link) virtual reality environment on postural control and balance skills of school-aged children with clinical diagnosis of ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRAIL | Experimental | Device: exergames with GRAIL virtual immersive reality environment |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- a clinical diagnosis of ASD
- All participants were required to have estimated FSIQ of 80 or above
Key exclusion criteria (5 listed)
- using any stimulant or non-stimulant medication that affects the central nervous system
- having an identified genetic disorder
- having vision or hearing problems
- suffering from chronic or acute medical illness
- presence of epilepsy
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 |
|---|---|---|
| exergames with GRAIL virtual immersive reality environmentThe participants will perform exergames on GRAIL immersive virtual reality to improve balance (e.g. load shifts, exercises with adaptations to motor perturbations). GRAIL can provide proprioceptive and visual feedback to participants. | Device | GRAIL |
Primary outcome
experimental balance assessment
Time frame: approximately 6 weeks after starting the intervention
Balance assessment through the evaluation (with both open and closed eyes) of the center of pression using the GRAIL platform
Movement Assessment Battery for Children 2 (MABC2) (Henderson et al., 2007).
Time frame: approximately 6 weeks after starting the intervention
The MABC2 consists of eight subtests that evaluate three components of motor proficiency: manual dexterity, ball skills, and static and dynamic balance. For the MABC2, higher scores are indicative of better motor performance.
4 secondary outcomes
Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007).
Time frame: approximately 6 weeks after starting the intervention
assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill the dominant side at toe-off
Time frame: approximately 6 weeks after starting the intervention
assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis
Time frame: approximately 6 weeks after starting the intervention
evaluation of gait features using the GRAIL (Motekforce Link)
Time frame: approximately 6 weeks after starting the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Results publication: PubMed 30618953Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.
- Derived from this study: PubMed 40869441Falivene A, Scaccabarozzi G, Busti Ceccarelli S, Molteni M, Klingels K, Verbecque E, Storm FA, Biffi E, Crippa A. Virtual Reality-Based Postural Balance Training in Autistic Children: A Pilot Randomized Controlled Trial. J Clin Med. 2025 Aug 8;14(16):5616. doi: 10.3390/jcm14165616.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exergames with GRAIL virtual immersive reality environment in people with Autism Spectrum Disorder, 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 5 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: finished, as of the sponsor's last update on 29 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
experimental balance assessment (time frame: approximately 6 weeks after starting the intervention). 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?
On the ClinicalTrials.gov record for NCT04276571, which also lists 2 linked publications.
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 29 Sep 2023.