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

Autism Spectrum Disorder Clinical Trial

— BRAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276571
• Other study ID #: GIP-679
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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.

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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