BlindnessNCT06334614
iReach: a Rehabilitative Medical Device
A study testing iReach in people with Blindness and Visual Impairment, run by Istituto Italiano di Tecnologia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Blindness, Visual Impairment
- What is being tested?
- iReach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 8 Dec 2024to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: iReach: a Novel Medical Device for Early Intervention for Visually Impaired Infants.
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.
Read the detailed description
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:
- To verify that the number of adverse events is zero, considering reports from the attending physician;
- To assess improvements in stationary and locomotion abilities, assessed with the Peabody Developmental Motor Scale (PDMS-2) indices;
- To evaluate further improvements in i) reaction time (s) and frequency and accuracy of response (%) to uni- and multisensory (audio-tactile) stimulations; ii) time to reach and grasp an object (s); iii) number of attempts required to reach and grasp an object (%); iv) number of times the midline of the body is crossed to reach a lateral object (%); v) number of times an object is grasped with two hands if it is larger than the hand (%). These parameters will be extracted from video recordings;
- To highlight changes in EEG power (dB) in the alpha band (8-12 Hz) measured in the occipital scalp area following rehabilitation with iReach. 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)
- Conditions
- Blindness, Visual Impairment
- Being tested
- iReach
- Keywords
- blindness, infants, rehabilitation, multisensory motor training, medical device
- Medical subject headings
- Blindness, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iReachDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| iReach Device group | Experimental | The iReach Device group will undergo the clinical trial with the device in addition to the normal clinical activity Receives: Device: iReach |
| Normal clinical activity group | No intervention | The Normal clinical activity group will continue their normal clinical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device Adverse Events
Verification of the absence of device adverse events in the use of the medical device (MD);
Measured: Month 1 - Month 12, the entire duration of the clinical trial
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Month 1 - Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start8 Dec 2024 (estimated)
- Primary completion8 May 2025 (estimated)
- Study completion8 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BlindnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Italiano di Tecnologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334614
- Sponsor's protocol ID
- IIT_iReach
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34051686Cappagli 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.
PubMed 26613827Cappagli 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.
PubMed 30824830Finocchietti 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.
PubMed 26738148Gori 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.
PubMed 34555348Setti 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.
PubMed 34647755Vercillo 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.
PubMed 25999825
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iReach: a Novel Medical Device for Early Intervention for Visually Impaired Infants.
- ClinicalTrials.gov ID
- NCT06334614
- Acronym / sponsor ID
- IIT_iReach
- Conditions
- Blindness, Visual Impairment
- Keywords
- blindness, infants, rehabilitation, multisensory motor training, medical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Istituto Italiano di TecnologiaUniversity, hospital or other
- Study start
- 8 Dec 2024 (estimated)
- Primary completion
- 8 May 2025 (estimated)
- Study completion
- 8 Dec 2025 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To verify that the number of adverse events is zero, considering reports from the attending physician;
- To assess improvements in stationary and locomotion abilities, assessed with the Peabody Developmental Motor Scale (PDMS-2) indices;
- To evaluate further improvements in i) reaction time (s) and frequency and accuracy of response (%) to uni- and multisensory (audio-tactile) stimulations; ii) time to reach and grasp an object (s); iii) number of attempts required to reach and grasp an object (%); iv) number of times the midline of the body is crossed to reach a lateral object (%); v) number of times an object is grasped with two hands if it is larger than the hand (%). These parameters will be extracted from video recordings;
- To highlight changes in EEG power (dB) in the alpha band (8-12 Hz) measured in the occipital scalp area following rehabilitation with iReach. 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iReach Device group | Experimental | Device: iReachThe iReach Device group will undergo the clinical trial with the device in addition to the normal clinical activity |
| Normal clinical activity group | No intervention | –The Normal clinical activity group will continue their normal clinical activity |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iReachThe 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. | Device | iReach Device group |
Primary outcome
Incidence of Device Adverse Events
Time frame: Month 1 - Month 12, the entire duration of the clinical trial
Verification of the absence of device adverse events in the use of the medical device (MD);
4 secondary outcomes
Change in motor skills after training with iReach medical device
Time frame: Month 3 - Month 12
Perceptual responses to multisensory stimuli
Time frame: Month 1 - Month 12
Change in motor abilities following the rehabilitation with the iReach medical device
Time frame: Month 1 - Month 12
Variation in the power of the cortical activity following the rehabilitation with the iReach medical device
Time frame: Month 1 - Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 34051686Campus 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.
- Background: PubMed 26613827Cappagli 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.
- Background: PubMed 30824830Cappagli 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.
- Background: PubMed 26738148Finocchietti 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.
- Background: PubMed 34555348Gori 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.
- Background: PubMed 34647755Setti 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.
- Background: PubMed 25999825Vercillo 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.
- MySpace/iReach websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing iReach in people with Blindness and Visual Impairment, run by Istituto Italiano di Tecnologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter Setti, PhD (+ 393396618515, walter.setti@iit.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device Adverse Events (time frame: Month 1 - Month 12, the entire duration of the clinical trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334614, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.