Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334614
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-20
Brief Title:
iReach a Rehabilitative Medical Device
Sponsor:
Istituto Italiano di Tecnologia
Organization:
Istituto Italiano di Tecnologia
Study Overview
Official Title:
iReach a Novel Medical Device for Early Intervention for Visually Impaired Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
1 To verify that the number of adverse events is zero considering reports from the attending physician
2 To assess improvements in stationary and locomotion abilities assessed with the Peabody Developmental Motor Scale PDMS-2 indices
3 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
4 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 ie 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 ie 3-6 months 6-12 months 12-36 months
In detail the goals of the current clinical trial are
1 To verify that the number of adverse events is zero considering reports from the attending physician
2 To assess improvements in stationary and locomotion abilities assessed with the Peabody Developmental Motor Scale PDMS-2 indices
3 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
4 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 ie 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 ie 3-6 months 6-12 months 12-36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None