BlindnessNCT06364605

MySpace: the Role of Vision in Representing Space

A study testing Rehabilitation with the iReach novel multisensory medical device in people with Blindness and Visual Impairment, run by Istituto Italiano di Tecnologia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 3 months and olderHealthy volunteers can take part
Conditions the study is for: Blindness, Visual Impairment
What is being tested?: Rehabilitation with the iReach novel multisensory medical device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 720 participants
Where: 1 siteItaly
Study dates: 3 May 2021to 31 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 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Having provided (by the subject or the parent/guardian) consent to be contacted through one of the recruitment channels established by the Italian Institute of Technology or voluntary enrollment;
Signature of the informed consent (by the subject or the parent/guardian);
Absence of other disabilities/conditions/comorbidities that would prevent participation and/or ensure patient safety during the execution of the tests and/or guarantee the quality/reliability of the data. This point is acquired through Informed Consent, in the section expressly acknowledging the following reasons for ineligibility to participate in the study: tactile hypersensitivity (specifically assessing equipment tolerance), taking neuroactive drugs and substances and having taken them in the last six months, comorbidity with another pathology;
Being affected, to the best of their knowledge, by pathologies of the central nervous system, and having experienced epileptic episodes, even minor ones, and convulsive crises in general, even in childhood;
The participating subjects may have typical or atypical development (i.e., group with visual disability). In the case of visual impairment, the disability should be congenital (from birth) or late onset. Furthermore, the following requirements must be met: subjects with visual disabilities must be classified according to current diagnostic rules, with visual problems present from birth or occurring later, with residual vision ranging from 0.5-1.3 LogMAR in the case of low vision or lower than 1.3 LogMAR in the case of blindness;
Age range required for each phase and configuration: Blind adults (≥ 18 years old):
Phase 1; Phase 2; Phase 3; Typical adults (≥ 18 years old): Phase 1; Phase 2; Phase 3; Blind minors (3 months < age < 18 years old): All phases; Typical minors (3 months < age < 18 years old): All phases; Adequate cognitive capacity for age. In particular, recognized scales such as the WISC9 scale will be used as a reference parameter to assess cognitive capacity.

Who cannot join

Additional disabilities besides visual impairment (e.g., individuals who are both visually and hearing impaired);
Absence of the signature on the informed consent form or incomplete consent regarding acknowledgment of the incompatibilities for participation in the study;
IQ values below the threshold of normality according to one of the recognized international scales;
Preterm birth.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Unit For Visually Impaired People
Genova, 16152

Other trials in Italy

About this study

Official title: MySpace: the Role of Vision on Perceptual Space Representation

My Space aims to identify the ontogenesis of spatial representation through cross-sectional and longitudinal studies in infants, children, and adolescents with typical and atypical development (visual impairments). The results will serve for the design and development of a novel multisensory device for sensorimotor rehabilitation in blind children from the early stages of life.

Read the detailed description

MySpace is an interventional neuropsychology study purely for scientific purposes, with no diagnostic or therapeutic aims. The project aims to define the role of vision in generating uni- and multi-sensory spatial representations (audio/tactile), essential for proper interaction with the surrounding environment. The project will focus on studying spatial deficits and reorganization mechanisms present in the absence of vision from the early years of development. The results will allow drawing overall conclusions on how we perceive the world and develop rehabilitative protocols to improve the quality of life of individuals with visual sensory disabilities. In detail, the project is divided into 4 macro-objectives:

Study of the role of vision in the development of uni-sensory spatial representations (Phase 1) through experimental procedures at the behavioral and cortical levels. This phase aims to understand the specific temporal windows within which auditory and tactile spatial representations develop in visually impaired children. This phase involves infants and children in an age range from 3 months to 16 years old, with typical and atypical development (visual disabilities), as well as sighted adults and those with visual disabilities. This phase includes the use of behavioral, kinematic, and neurophysiological techniques, employing EEG systems, to provide an assessment of a participant's response to sensory stimuli. Number of participants: 50 sighted adults, 20 blind adults, 60 blind children, 100 sighted children;
Role of vision in the development of multi-sensory spatial representations (Phase 2) The objective of Phase 2 is to define, the role of vision in the generation of audio-tactile multi-sensory representations. In this phase, both infants and children ranging from 3 months to 16 years old, with and without visual disabilities, as well as adults with and without visual disabilities, will participate. In Phase 2, experiments will be conducted using behavioral, psychophysical, and motion tracking methods. The neurophysiological architecture associated with multi-sensory integration will be studied using EEG. Number of participants: 80 sighted adults, 20 blind adults, 60 blind children, 120 sighted children;
Neuro-imaging of spatial representation (Phase 3) Phase 3 will study the mechanisms of cortical reorganization following the absence of vision in the early years of life, particularly those concerning the visual cortex responsible for processing spatial information. This phase involves a single setup in which both adults and children ranging from 3 months to 16 years old take part. This phase hypothesizes that structural changes resulting from a visual disability may emerge during the early years of life when spatial perceptual abilities develop and cortical reorganization begins. In this phase, each participant will undergo structural MRI recording to investigate the structural changes observed during growth in both typical cases and cases of visual disability. Number of participants: 50 sighted adults, 20 blind adults, 30 blind children, 30 sighted children;
Multi-sensory training (Phase 4) The objective of Phase 4 is the development and evaluation of multi-sensory training aimed at helping visually impaired children improve their spatial representation ability and overcome limitations due to the absence of vision. This phase involves infants with both typical and atypical development (i.e., visual disabilities) aged between 3 and 36 months of life. Experimental sessions will be conducted partly at home and partly in clinical centers participating in the project. Non-invasive and painless auditory and tactile stimuli will be employed, which may come from devices applied to the child's body or from sound-producing objects placed in the environment. For data analysis, video recordings will be carried out, and motion-tracking procedures will be employed. To assess the effectiveness of the training, children will be retested approximately 4 months after the end of the training, following the procedures outlined in Phases 1 and 2. These evaluative sessions will help understand if the effects of rehabilitation persist over time. Additionally, during the initial and final phases of the training, and in the follow-up, EEG techniques will be used to assess any changes in cortical activation due to the training. Number of participants:55 blind children, 55 sighted children.

The preliminary data will utilize the Power Analysis method to calculate the minimum sample size required to achieve a correct effect size for a given dimension. The data will be analyzed using both parametric and non-parametric tests, and differences between groups will be assessed with t-tests, ANOVA, TANCOVA, and linear mixed models where appropriate. An appropriate post-hoc test will be conducted if significance is found. The significance level will be considered at p<0.05. Where necessary, parametric techniques will be replaced by non-parametric equivalents. The standard software used will include: Matlab, R, Origin, Statistica, and SPSS, recognized in the research field. For the analysis of electroencephalographic data, EEGlab and/or Fieldtrip toolboxes will be utilized. For functional magnetic resonance imaging data analysis, the FSL and/or SPM toolboxes will be employed.

Conditions: Blindness, Visual Impairment
Being tested: Rehabilitation with the iReach novel multisensory medical device
Keywords: blindness, infants, spatial representations, EEG, child development, 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.

Rehabilitation with the iReach novel multisensory medical deviceDevice
From the results of Phases 1,2 and 3, in Phase 4 a medical device for spatial and sensorimotor rehabilitation in infants aged 3 to 36 months will be tested and developed.

Study groups in NCT06364605
Study group	Role	What they receive
iReach Device Group	Experimental	Not described Receives: Device: Rehabilitation with the iReach novel multisensory medical device

What is being measured

The primary outcome is the main question the study is designed to answer.

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: Through study completion, an average of 5 years
Stimuli velocity perception
Estimation of the speed of a moving stimulus (m/s)
Measured: Through study completion, an average of 5 years
Distance stimuli perception
Estimation of the the distance traveled by a moving stimulus (m), along with an estimate of the error made in identifying the endpoint of the stimulus by the participant (m).
Measured: Through study completion, an average of 5 years
Eye movements
Eye movements are evaluated in terms of fixation duration (s) and time to first fixation (TTFF) (ms).
Measured: Years 3-5
Saccade Analysis
Estimation of saccade length (pixels)
Measured: Years 3-5
ERP evaluation and analysis
Evaluation of the Event-Related-Potentials (ERPs) in terms of the number of spikes and their Amplitude (μV);
Measured: Through study completion, an average of 5 years
Power of the cortical activity
Evaluation of power expressed by the alpha band (8-12 Hz) of the EEG recorded in the occipital area (dB).
Measured: Through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 202131 Dec 2025

First posted15 Apr 2024
Study start3 May 2021
Primary completion26 Jun 2021
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 720 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06364605
Sponsor's protocol ID: IIT_UVIP_MySpace
Status last verified: Mar 2024
First submitted: 26 Mar 2024
Last updated: 15 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Gori M. Multisensory Integration and Calibration in Children and Adults with and without Sensory and Motor Disabilities. Multisens Res. 2015;28(1-2):71-99. doi: 10.1163/22134808-00002478.
PubMed 26152053
Gori M, Sandini G, Burr D. Development of visuo-auditory integration in space and time. Front Integr Neurosci. 2012 Sep 17;6:77. doi: 10.3389/fnint.2012.00077. eCollection 2012.
PubMed 23060759
Gori M, Sandini G, Martinoli C, Burr DC. Impairment of auditory spatial localization in congenitally blind human subjects. Brain. 2014 Jan;137(Pt 1):288-93. doi: 10.1093/brain/awt311. Epub 2013 Nov 21.
PubMed 24271326
Finocchietti S, Cappagli G, Gori M. Encoding audio motion: spatial impairment in early blind individuals. Front Psychol. 2015 Sep 7;6:1357. doi: 10.3389/fpsyg.2015.01357. eCollection 2015.
PubMed 26441733
Cappagli G, Gori M. Auditory spatial localization: Developmental delay in children with visual impairments. Res Dev Disabil. 2016 Jun-Jul;53-54:391-8. doi: 10.1016/j.ridd.2016.02.019. Epub 2016 Mar 19.
PubMed 27002960
Barutchu A, Crewther DP, Crewther SG. The race that precedes coactivation: development of multisensory facilitation in children. Dev Sci. 2009 Apr;12(3):464-73. doi: 10.1111/j.1467-7687.2008.00782.x.
PubMed 19371371
Inuggi A, Pichiecchio A, Ciacchini B, Signorini S, Morelli F, Gori M. Multisystemic Increment of Cortical Thickness in Congenital Blind Children. Cereb Cortex Commun. 2020 Oct 9;1(1):tgaa071. doi: 10.1093/texcom/tgaa071. eCollection 2020.
PubMed 34296131
Mongodi S, Ottonello G, Viggiano R, Borrelli P, Orcesi S, Pichiecchio A, Balottin U, Mojoli F, Iotti GA. Ten-year experience with standardized non-operating room anesthesia with Sevoflurane for MRI in children affected by neuropsychiatric disorders. BMC Anesthesiol. 2019 Dec 18;19(1):235. doi: 10.1186/s12871-019-0897-1.
PubMed 31852450
Erden G, Yigit I, Celik C, Guzey M. The diagnostic utility of the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV) in identification of gifted children. J Gen Psychol. 2022 Jul-Sep;149(3):371-390. doi: 10.1080/00221309.2020.1862038. Epub 2020 Dec 22.
PubMed 33350363
Lawrence A, Choe DE. Mobile Media and Young Children's Cognitive Skills: A Review. Acad Pediatr. 2021 Aug;21(6):996-1000. doi: 10.1016/j.acap.2021.01.007. Epub 2021 Jan 21.
PubMed 33486100
Cappagli 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 26613827
Vercillo T, Burr D, Sandini G, Gori M. Children do not recalibrate motor-sensory temporal order after exposure to delayed sensory feedback. Dev Sci. 2015 Sep;18(5):703-12. doi: 10.1111/desc.12247. Epub 2014 Nov 28.
PubMed 25444457
Tonelli A, Brayda L, Gori M. Task-dependent calibration of auditory spatial perception through environmental visual observation. Front Syst Neurosci. 2015 Jun 2;9:84. doi: 10.3389/fnsys.2015.00084. eCollection 2015.
PubMed 26082692
Cuturi LF, Gori M. The Effect of Visual Experience on Perceived Haptic Verticality When Tilted in the Roll Plane. Front Neurosci. 2017 Dec 6;11:687. doi: 10.3389/fnins.2017.00687. eCollection 2017.
PubMed 29270109
Aggius-Vella E, Campus C, Finocchietti S, Gori M. Audio Spatial Representation Around the Body. Front Psychol. 2017 Nov 3;8:1932. doi: 10.3389/fpsyg.2017.01932. eCollection 2017.
PubMed 29249999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Blindness trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MySpace: the Role of Vision on Perceptual Space Representation
ClinicalTrials.gov ID: NCT06364605
Acronym / sponsor ID: IIT_UVIP_MySpace
Conditions: Blindness, Visual Impairment
Keywords: blindness, infants, spatial representations, EEG, child development, medical device
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 720 participants (estimated)
Lead sponsor: Istituto Italiano di TecnologiaUniversity, hospital or other
Study start: 3 May 2021 (actual)
Primary completion: 26 Jun 2021 (actual)
Study completion: 31 Dec 2025 (estimated)
First posted: 15 Apr 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.

Detailed description

Study of the role of vision in the development of uni-sensory spatial representations (Phase 1) through experimental procedures at the behavioral and cortical levels. This phase aims to understand the specific temporal windows within which auditory and tactile spatial representations develop in visually impaired children. This phase involves infants and children in an age range from 3 months to 16 years old, with typical and atypical development (visual disabilities), as well as sighted adults and those with visual disabilities. This phase includes the use of behavioral, kinematic, and neurophysiological techniques, employing EEG systems, to provide an assessment of a participant's response to sensory stimuli. Number of participants: 50 sighted adults, 20 blind adults, 60 blind children, 100 sighted children;
Role of vision in the development of multi-sensory spatial representations (Phase 2) The objective of Phase 2 is to define, the role of vision in the generation of audio-tactile multi-sensory representations. In this phase, both infants and children ranging from 3 months to 16 years old, with and without visual disabilities, as well as adults with and without visual disabilities, will participate. In Phase 2, experiments will be conducted using behavioral, psychophysical, and motion tracking methods. The neurophysiological architecture associated with multi-sensory integration will be studied using EEG. Number of participants: 80 sighted adults, 20 blind adults, 60 blind children, 120 sighted children;
Neuro-imaging of spatial representation (Phase 3) Phase 3 will study the mechanisms of cortical reorganization following the absence of vision in the early years of life, particularly those concerning the visual cortex responsible for processing spatial information. This phase involves a single setup in which both adults and children ranging from 3 months to 16 years old take part. This phase hypothesizes that structural changes resulting from a visual disability may emerge during the early years of life when spatial perceptual abilities develop and cortical reorganization begins. In this phase, each participant will undergo structural MRI recording to investigate the structural changes observed during growth in both typical cases and cases of visual disability. Number of participants: 50 sighted adults, 20 blind adults, 30 blind children, 30 sighted children;
Multi-sensory training (Phase 4) The objective of Phase 4 is the development and evaluation of multi-sensory training aimed at helping visually impaired children improve their spatial representation ability and overcome limitations due to the absence of vision. This phase involves infants with both typical and atypical development (i.e., visual disabilities) aged between 3 and 36 months of life. Experimental sessions will be conducted partly at home and partly in clinical centers participating in the project. Non-invasive and painless auditory and tactile stimuli will be employed, which may come from devices applied to the child's body or from sound-producing objects placed in the environment. For data analysis, video recordings will be carried out, and motion-tracking procedures will be employed. To assess the effectiveness of the training, children will be retested approximately 4 months after the end of the training, following the procedures outlined in Phases 1 and 2. These evaluative sessions will help understand if the effects of rehabilitation persist over time. Additionally, during the initial and final phases of the training, and in the follow-up, EEG techniques will be used to assess any changes in cortical activation due to the training. Number of participants:55 blind children, 55 sighted children.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
iReach Device Group	Experimental	Device: Rehabilitation with the iReach novel multisensory medical device

Who may qualify

Ages: 3 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Having provided (by the subject or the parent/guardian) consent to be contacted through one of the recruitment channels established by the Italian Institute of Technology or voluntary enrollment;
Signature of the informed consent (by the subject or the parent/guardian);
Absence of other disabilities/conditions/comorbidities that would prevent participation and/or ensure patient safety during the execution of the tests and/or guarantee the quality/reliability of the data. This point is acquired through Informed Consent, in the section expressly acknowledging the following reasons for ineligibility to participate in the study: tactile hypersensitivity (specifically assessing equipment tolerance), taking neuroactive drugs and substances and having taken them in the last six months, comorbidity with another pathology;
Being affected, to the best of their knowledge, by pathologies of the central nervous system, and having experienced epileptic episodes, even minor ones, and convulsive crises in general, even in childhood;
The participating subjects may have typical or atypical development (i.e., group with visual disability). In the case of visual impairment, the disability should be congenital (from birth) or late onset. Furthermore, the following requirements must be met: subjects with visual disabilities must be classified according to current diagnostic rules, with visual problems present from birth or occurring later, with residual vision ranging from 0.5-1.3 LogMAR in the case of low vision or lower than 1.3 LogMAR in the case of blindness;

Key exclusion criteria (4 listed)

Additional disabilities besides visual impairment (e.g., individuals who are both visually and hearing impaired);
Absence of the signature on the informed consent form or incomplete consent regarding acknowledgment of the incompatibilities for participation in the study;
IQ values below the threshold of normality according to one of the recognized international scales;
Preterm birth.

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
Rehabilitation with the iReach novel multisensory medical deviceFrom the results of Phases 1,2 and 3, in Phase 4 a medical device for spatial and sensorimotor rehabilitation in infants aged 3 to 36 months will be tested and developed.	Device	iReach Device Group

Primary outcome

Perceptual responses to multisensory stimuli
Time frame: Through study completion, an average of 5 years
Evaluation of the number of correct responses and reaction times (in seconds), to uni- and multisensory (audio-tactile) stimuli.
Stimuli velocity perception
Time frame: Through study completion, an average of 5 years
Estimation of the speed of a moving stimulus (m/s)
Distance stimuli perception
Time frame: Through study completion, an average of 5 years
Estimation of the the distance traveled by a moving stimulus (m), along with an estimate of the error made in identifying the endpoint of the stimulus by the participant (m).
Eye movements
Time frame: Years 3-5
Eye movements are evaluated in terms of fixation duration (s) and time to first fixation (TTFF) (ms).
Saccade Analysis
Time frame: Years 3-5
Estimation of saccade length (pixels)
ERP evaluation and analysis
Time frame: Through study completion, an average of 5 years
Evaluation of the Event-Related-Potentials (ERPs) in terms of the number of spikes and their Amplitude (μV);
Power of the cortical activity
Time frame: Through study completion, an average of 5 years
Evaluation of power expressed by the alpha band (8-12 Hz) of the EEG recorded in the occipital area (dB).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
Results publication: PubMed 26152053Gori M. Multisensory Integration and Calibration in Children and Adults with and without Sensory and Motor Disabilities. Multisens Res. 2015;28(1-2):71-99. doi: 10.1163/22134808-00002478.
Results publication: PubMed 23060759Gori M, Sandini G, Burr D. Development of visuo-auditory integration in space and time. Front Integr Neurosci. 2012 Sep 17;6:77. doi: 10.3389/fnint.2012.00077. eCollection 2012.
Results publication: PubMed 24271326Gori M, Sandini G, Martinoli C, Burr DC. Impairment of auditory spatial localization in congenitally blind human subjects. Brain. 2014 Jan;137(Pt 1):288-93. doi: 10.1093/brain/awt311. Epub 2013 Nov 21.
Results publication: PubMed 26441733Finocchietti S, Cappagli G, Gori M. Encoding audio motion: spatial impairment in early blind individuals. Front Psychol. 2015 Sep 7;6:1357. doi: 10.3389/fpsyg.2015.01357. eCollection 2015.
Results publication: PubMed 27002960Cappagli G, Gori M. Auditory spatial localization: Developmental delay in children with visual impairments. Res Dev Disabil. 2016 Jun-Jul;53-54:391-8. doi: 10.1016/j.ridd.2016.02.019. Epub 2016 Mar 19.
Results publication: PubMed 19371371Barutchu A, Crewther DP, Crewther SG. The race that precedes coactivation: development of multisensory facilitation in children. Dev Sci. 2009 Apr;12(3):464-73. doi: 10.1111/j.1467-7687.2008.00782.x.
Results publication: PubMed 34296131Inuggi A, Pichiecchio A, Ciacchini B, Signorini S, Morelli F, Gori M. Multisystemic Increment of Cortical Thickness in Congenital Blind Children. Cereb Cortex Commun. 2020 Oct 9;1(1):tgaa071. doi: 10.1093/texcom/tgaa071. eCollection 2020.
Results publication: PubMed 31852450Mongodi S, Ottonello G, Viggiano R, Borrelli P, Orcesi S, Pichiecchio A, Balottin U, Mojoli F, Iotti GA. Ten-year experience with standardized non-operating room anesthesia with Sevoflurane for MRI in children affected by neuropsychiatric disorders. BMC Anesthesiol. 2019 Dec 18;19(1):235. doi: 10.1186/s12871-019-0897-1.
Results publication: PubMed 33350363Erden G, Yigit I, Celik C, Guzey M. The diagnostic utility of the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV) in identification of gifted children. J Gen Psychol. 2022 Jul-Sep;149(3):371-390. doi: 10.1080/00221309.2020.1862038. Epub 2020 Dec 22.
Results publication: PubMed 33486100Lawrence A, Choe DE. Mobile Media and Young Children's Cognitive Skills: A Review. Acad Pediatr. 2021 Aug;21(6):996-1000. doi: 10.1016/j.acap.2021.01.007. Epub 2021 Jan 21.
Results publication: 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.
Results publication: PubMed 25444457Vercillo T, Burr D, Sandini G, Gori M. Children do not recalibrate motor-sensory temporal order after exposure to delayed sensory feedback. Dev Sci. 2015 Sep;18(5):703-12. doi: 10.1111/desc.12247. Epub 2014 Nov 28.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation with the iReach novel multisensory medical device in people with Blindness and Visual Impairment, run by Istituto Italiano di Tecnologia at 1 site in Italy.

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 7 inclusion and 4 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceptual responses to multisensory stimuli (time frame: Through study completion, an average of 5 years). The study lists 7 primary outcomes in all. 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 NCT06364605, which also lists 23 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 15 Apr 2024.