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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
exergames with GRAIL virtual immersive reality environment
Sponsored by
IRCCS Eugenio Medea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring motor abilities

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scientific Institute IRCCS E. Medea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GRAIL

No treatment

Arm Description

Outcomes

Primary Outcome Measures

experimental balance assessment
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).
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

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

Full Information

First Posted
February 18, 2020
Last Updated
September 28, 2023
Sponsor
IRCCS Eugenio Medea
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1. Study Identification

Unique Protocol Identification Number
NCT04276571
Brief Title
EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality
Acronym
BRAVE
Official Title
EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
motor abilities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GRAIL
Arm Type
Experimental
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
exergames with GRAIL virtual immersive reality environment
Intervention Description
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 Outcome Measure Information:
Title
experimental balance assessment
Description
Balance assessment through the evaluation (with both open and closed eyes) of the center of pression using the GRAIL platform
Time Frame
approximately 6 weeks after starting the intervention
Title
Movement Assessment Battery for Children 2 (MABC2) (Henderson et al., 2007).
Description
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.
Time Frame
approximately 6 weeks after starting the intervention
Secondary Outcome Measure Information:
Title
Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007).
Description
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.
Time Frame
approximately 6 weeks after starting the intervention
Title
assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill the dominant side at toe-off
Description
assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill
Time Frame
approximately 6 weeks after starting the intervention
Title
assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis
Description
assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis
Time Frame
approximately 6 weeks after starting the intervention
Title
evaluation of gait features using the GRAIL (Motekforce Link)
Description
evaluation of gait features using the GRAIL (Motekforce Link)
Time Frame
approximately 6 weeks after starting the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Scientific Institute IRCCS E. Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30618953
Citation
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.
Results Reference
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EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality

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