An interventional study of iReach in Blindness and Visual Impairment, sponsored by Istituto Italiano di Tecnologia. Not yet recruiting. Open to participants aged 3 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Istituto Italiano di Tecnologia · Not applicable, Interventional, and Treatment
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.
Development and clinical validation of a novel multisensory medical device: iReach. This device will be used for the rehabilitation and recovery of spatial and sensorimotor abilities compromised by early visual impairment (i.e., blindness or moderate to severe low vision) in children aged between 3 and 36 months. In addition to its clinical value, the investigators aim to fill a technological and methodological gap. Currently, there are no certified medical devices for early intervention, that is, systems that are intuitive, simple, and designed for rehabilitation in the early stages of development.
In detail, the goals of the current clinical trial are:
iReach, is composed of two devices called Anchors, and a reference Tag, that can be placed either on both the body or external objects. Each Anchor measures its distance from the Tag and translates it into sensory feedback, whose intensity and time duration parameters are configurable. iReach can emit acoustic, vibrational, and RGB light stimuli, either alone or in combination, and is turned on via a button located on the external cover, which is manufactured through 3D printing.
This study is divided into two phases: usability and rehabilitation. The usability phase is aimed at defining the temporal durations of audio-tactile stimulations that will then be used in the rehabilitation phase. The patients enrolled in the iReach Device group of this phase will be involved in a one-month rehabilitation procedure (i.e., training) and will perform activities with iReach presented in the form of games that target localization, locomotion, grasping, and reaching skills. The training will be conducted both at home and at the clinical center and will be preceded and followed by two identical experimental sessions (pre- and post-training), which will monitor improvements in spatial and sensorimotor abilities following rehabilitation. Finally, an additional follow-up experimental session is planned four months after the post-training to verify whether these improvements are still present or not, both behaviorally and cortically. The participants enrolled in the Normal clinical activity group of the experimental phase will only be involved in the pre- and post-training sessions and the follow-up session without undergoing rehabilitation with iReach. The tasks the participants will have to undergo are designed for the specific age bin (i.e., 3-6 months, 6-12 months, 12-36 months)
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's planned enrollment of 55 is above the median of 37 across 101 interventional studies indexed under Blindness.
Browse Blindness studies →Istituto Italiano di Tecnologia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The iReach Device group will undergo the clinical trial with the device in addition to the normal clinical activity
Device: iReach
The Normal clinical activity group will continue their normal clinical activity
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.
Incidence of Device Adverse Events
Verification of the absence of device adverse events in the use of the medical device (MD);
Time frame: Month 1 - Month 12, the entire duration of the clinical trial
Change in motor skills after training with iReach medical device
The assessment of the change in certain motor skills (e.g., stability, and locomotion) after one month of intensive use of iReach. These changes will be quantified through the indices of the Peabody Developmental Motor Scales -2 (PDMS-2). The tasks included in these scales will be adapted to be executable by children with visual impairments. The PDMS-2 scales are widely used in clinical practice and allow for robust and reliable measurements. Higher scores result in better outcomes. The performance values are quantified through an indicator named "Total Motor Quotient," which spans from a minimum range equal to 35-69, representing a strong deficit, to a maximum range of 131-165, indicating the best performance.
Time frame: Month 3 - Month 12
Perceptual responses to multisensory stimuli
Evaluation of the number of correct responses and reaction times (in seconds), to uni- and multisensory (audio-tactile) stimuli.
Time frame: Month 1 - Month 12
Change in motor abilities following the rehabilitation with the iReach medical device
Evaluation of the changes in motor tasks in terms of: i) time to reach and grasp an object (in seconds) ii) number of attempts required to reach and grasp an object; iii) number of times the midline of the body is crossed to reach a lateral object; iv) number of times an object is grasped with two hands when its size exceeds that of the hand.
Time frame: Month 1 - Month 12
Variation in the power of the cortical activity following the rehabilitation with the iReach medical device
Evaluation of the variation in power expressed by the alpha band (8-12 Hz) of the EEG recorded in the occipital area (dB).
Time frame: Month 1 - Month 12
No study locations are listed for this record.
Plan to share: Yes
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Istituto Italiano di Tecnologia