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

Sponsor
IRCCS Eugenio Medea (Other)
Overall Status
Recruiting
CT.gov ID
NCT04276571
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
38.4
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: exergames with GRAIL virtual immersive reality environment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality
Actual Study Start Date :
Oct 18, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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.

  2. 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

  3. 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

  4. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scientific Institute IRCCS E. Medea Bosisio Parini Lecco Italy 23842

Sponsors and Collaborators

  • IRCCS Eugenio Medea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IRCCS Eugenio Medea
ClinicalTrials.gov Identifier:
NCT04276571
Other Study ID Numbers:
  • GIP-679
First Posted:
Feb 19, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by IRCCS Eugenio Medea
motor abilities
Additional relevant MeSH terms:
Autism Spectrum Disorder

Study Results

No Results Posted as of Mar 31, 2022