NCT04276571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

3.2 years

First QC Date

February 18, 2020

Last Update Submit

September 28, 2023

Conditions

Autism Spectrum Disorder

Keywords

motor abilities

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

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

    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

    approximately 6 weeks after starting the intervention

  • 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)

    approximately 6 weeks after starting the intervention

Study Arms (2)

GRAIL

EXPERIMENTAL
Device: exergames with GRAIL virtual immersive reality environment

No treatment

NO INTERVENTION

Interventions

exergames with GRAIL virtual immersive reality environmentDEVICE

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.

GRAIL

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • a clinical diagnosis of ASD
  • All participants were required to have estimated FSIQ of 80 or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (2)

  • 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.

    PMID: 30618953RESULT

  • Falivene A, Scaccabarozzi G, Busti Ceccarelli S, Molteni M, Klingels K, Verbecque E, Storm FA, Biffi E, Crippa A. Virtual Reality-Based Postural Balance Training in Autistic Children: A Pilot Randomized Controlled Trial. J Clin Med. 2025 Aug 8;14(16):5616. doi: 10.3390/jcm14165616.

    PMID: 40869441DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 19, 2020

Study Start

October 18, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)