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

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 Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: exergames with GRAIL virtual immersive reality environment

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilia Biffi, PhD; Phone Number: +39031877862; Email: emilia.biffi@lanostrafamiglia.it

Study Locations

• Italy
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • Scientific Institute IRCCS E. Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRAIL	Device: exergames 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.
No Intervention: No treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: motor abilities
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: GIP-679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No