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Clinical Trials/NCT04276571
NCT04276571
Completed
Not Applicable

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

IRCCS Eugenio Medea1 site in 1 country22 target enrollmentOctober 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
IRCCS Eugenio Medea
Enrollment
22
Locations
1
Primary Endpoint
experimental balance assessment
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 18, 2019
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
IRCCS Eugenio Medea
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis(approximately 6 weeks after starting the intervention)
  • Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007).(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(approximately 6 weeks after starting the intervention)
  • evaluation of gait features using the GRAIL (Motekforce Link)(approximately 6 weeks after starting the intervention)

Study Sites (1)

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