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

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: exergames with GRAIL virtual immersive reality environment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRAIL<br> | Device: exergames with GRAIL virtual immersive reality environment<br>* 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.<br>|
| No Intervention: No treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| experimental balance assessment | Balance assessment through the evaluation (with both open and closed eyes) of the center of pression using the GRAIL platform | 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. | approximately 6 weeks after starting the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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) | approximately 6 weeks after starting the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor abilities