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Completed

NCT Number: NCT04276571

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exergames with GRAIL virtual immersive reality environment

Device

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.

Primary outcomes

  1. 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

  2. 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

  1. Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007).

    Time frame: 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.

  2. assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill the dominant side at toe-off

    Time frame: approximately 6 weeks after starting the intervention

    assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill

  3. assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis

    Time frame: approximately 6 weeks after starting the intervention

    assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis

  4. evaluation of gait features using the GRAIL (Motekforce Link)

    Time frame: approximately 6 weeks after starting the intervention

    evaluation of gait features using the GRAIL (Motekforce Link)

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Acronym: BRAVE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 19, 2020
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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