iReach: a Rehabilitative Medical Device (NCT06334614) | Clinical Trial Compass
UnknownNot Applicable
iReach: a Rehabilitative Medical Device
55 participantsStarted 2024-12-08
Plain-language 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.
Who can participate
Age range
3 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Device Adverse Events
Timeframe: Month 1 - Month 12, the entire duration of the clinical trial