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EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality

EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04276571
Acronym
BRAVE
Enrollment
22
Registered
2020-02-19
Start date
2019-10-18
Completion date
2022-12-31
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

motor abilities

Brief 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.

Interventions

DEVICEexergames with GRAIL virtual immersive reality environment

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.

Sponsors

IRCCS Eugenio Medea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* a clinical diagnosis of ASD * All participants were required to have estimated FSIQ of 80 or above

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
experimental balance assessmentapproximately 6 weeks after starting the interventionBalance 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).approximately 6 weeks after starting the interventionThe 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.

Secondary

MeasureTime frameDescription
Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007).approximately 6 weeks after starting the interventionThe 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.
assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill the dominant side at toe-offapproximately 6 weeks after starting the interventionassessment of balance in response to perturbation applied by accelerating the dual-belt treadmill
assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysisapproximately 6 weeks after starting the interventionassessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis
evaluation of gait features using the GRAIL (Motekforce Link)approximately 6 weeks after starting the interventionevaluation of gait features using the GRAIL (Motekforce Link)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026