iReach: a Rehabilitative Medical Device

Launched by ISTITUTO ITALIANO DI TECNOLOGIA · Mar 27, 2024

Keywords

ClinConnect Summary

The iReach clinical trial is studying a new medical device designed to help young children with visual impairments improve their ability to understand space and movement. The trial will involve a one-month training program using this device to see if it can help children aged 3 to 36 months recover some of their spatial skills and improve brain function related to vision. This research aims to find out if the device can make a meaningful difference in the lives of these children.

To be eligible for this trial, children must be between 3 and 36 months old and have either normal vision or some level of visual impairment as assessed by specific tests. They should not have any other serious health issues, like neurological disorders or other sensory disabilities. Families interested in participating will need to provide informed consent, meaning they agree to let their child take part in the study after understanding its purpose and processes. Participants can expect a supportive environment where they will engage with the device during the training period, and the information gained from this trial may help improve future treatments for visual impairment in young children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• Exclusion Criteria:
• • 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;