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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Device: exergames with GRAIL virtual immersive reality environment

• Registration Number: NCT04276571
• Lead Sponsor: IRCCS Eugenio Medea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-18
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GRAIL	exergames with GRAIL virtual immersive reality environment	-

Primary Outcome Measures

Name	Time	Method
experimental balance assessment	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).	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Scientific Institute IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy