iReach: a Rehabilitative Medical Device

NCT06334614 | Not Yet Recruiting

• 1 other identifier: IIT_iReach
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The broad goal of this clinical trial is to demonstrate whether a one-month rehabilitative training with our medical device, iReach, can promote the recovery of spatial and sensorimotor abilities and the cortical reorganization process in children with visual impairment between 3 and 36 months of age.

Conditions

Blindness; Visual Impairment

Keywords

blindness; infants; rehabilitation; multisensory motor training; medical device

Outcome Measures

Primary Outcomes (1)

• Incidence of Device Adverse Events

  Verification of the absence of device adverse events in the use of the medical device (MD);

  Month 1 - Month 12, the entire duration of the clinical trial

Secondary Outcomes (4)

• Change in motor skills after training with iReach medical device

  Month 3 - Month 12

• Perceptual responses to multisensory stimuli

  Month 1 - Month 12

• Change in motor abilities following the rehabilitation with the iReach medical device

  Month 1 - Month 12

• Variation in the power of the cortical activity following the rehabilitation with the iReach medical device

  Month 1 - Month 12

Study Arms (2)

iReach Device group

EXPERIMENTAL

The iReach Device group will undergo the clinical trial with the device in addition to the normal clinical activity

Device: iReach

Normal clinical activity group

NO INTERVENTION

The Normal clinical activity group will continue their normal clinical activity

Interventions

iReach DEVICE

The iReach Device group will take part in playful multisensory motor and spatial activities for one month both at the clinic and at home with the medical device iReach.

iReach Device group

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Obtaining Informed Consent;
• Age between 3 and 36 months;
• Normal vision or visual acuity between 0 and 4.7 cy/deg, assessed using the Teller Acuity Cards;
• Absence of concurrent therapies during the experimentation;
• Adequate cognitive ability for their age, assessed using the Reynell-Zinkin, Bayley III, and/or Griffiths scales;

You may not qualify if:

• Children with neurological disorders or cognitive delays (assessed using the Reynell-Zinkin, Bayley III, and/or Griffiths scales);
• Children affected by other sensory disabilities in addition to visual impairment (e.g., deafness) or with motor disorders;
• Premature infants with early gestational age (\< 32 weeks);
• Children with diseases affecting the central nervous system or who have experienced epileptic seizures and/or convulsions in the six months before the start of the experimentation;
• Children with tactile hypersensitivity who are taking neuroactive drugs and substances or have taken them in the six months before the start of the experimentation;
• Children with auditory and/or peripheral motor disabilities;
• Children whose parents or legal guardians have not provided informed consent;

Sponsors & Collaborators

• Istituto Italiano di Tecnologia: lead

Related Publications (7)

• Campus C, Signorini S, Vitali H, De Giorgis V, Papalia G, Morelli F, Gori M. Sensitive period for the plasticity of alpha activity in humans. Dev Cogn Neurosci. 2021 Jun;49:100965. doi: 10.1016/j.dcn.2021.100965. Epub 2021 May 21.

  PMID: 34051686 BACKGROUND

• Cappagli G, Cocchi E, Gori M. Auditory and proprioceptive spatial impairments in blind children and adults. Dev Sci. 2017 May;20(3). doi: 10.1111/desc.12374. Epub 2015 Nov 27.

  PMID: 26613827 BACKGROUND

• Cappagli G, Finocchietti S, Cocchi E, Giammari G, Zumiani R, Cuppone AV, Baud-Bovy G, Gori M. Audio motor training improves mobility and spatial cognition in visually impaired children. Sci Rep. 2019 Mar 1;9(1):3303. doi: 10.1038/s41598-019-39981-x.

  PMID: 30824830 BACKGROUND

• Finocchietti S, Cappagli G, Ben Porquis L, Baud-Bovy G, Cocchi E, Gori M. Evaluation of the Audio Bracelet for Blind Interaction for improving mobility and spatial cognition in early blind children - A pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:7998-8001. doi: 10.1109/EMBC.2015.7320248.

  PMID: 26738148 BACKGROUND

• Gori M, Campus C, Signorini S, Rivara E, Bremner AJ. Multisensory spatial perception in visually impaired infants. Curr Biol. 2021 Nov 22;31(22):5093-5101.e5. doi: 10.1016/j.cub.2021.09.011. Epub 2021 Sep 22.

  PMID: 34555348 BACKGROUND

• Setti W, Cuturi LF, Engel I, Picinali L, Gori M. The influence of early visual deprivation on audio-spatial working memory. Neuropsychology. 2022 Jan;36(1):55-63. doi: 10.1037/neu0000776. Epub 2021 Oct 14.

  PMID: 34647755 BACKGROUND

• Vercillo T, Gori M. Attention to sound improves auditory reliability in audio-tactile spatial optimal integration. Front Integr Neurosci. 2015 May 7;9:34. doi: 10.3389/fnint.2015.00034. eCollection 2015.

  PMID: 25999825 BACKGROUND

Related Links

• MySpace/iReach website

MeSH Terms

Conditions

Blindness; Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Walter Setti, PhD

CONTACT

+ 393396618515; walter.setti@iit.it

Monica Gori, PhD

CONTACT

+ 393601021020; monica.gori@iit.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant masking because the clinical trial involves infants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 28, 2024
• Study Start: December 8, 2024
• Primary Completion: May 8, 2025
• Study Completion: December 8, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share