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Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment

Primary Purpose

Blindness, Blindness, Acquired, Low Vision

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Kinesthetic Navigational Training
Sponsored by
Smith-Kettlewell Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blindness focused on measuring blindness, plasticity, spatial memory, training, navigation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Behavioral Studies:

  • Vision from < 20/500 to NLP (No Light Perception)

Brain Imaging Studies:

  • Vision from < 20/500 to NLP
  • Within average gender range for height +/-1 standard deviation
  • Within average gender range for weight +/-1 standard deviation
  • Comfortable with MRI procedures

Exclusion Criteria:

Behavioral Studies:

  • Neurological deficits
  • Inability to normally control lower or upper extremities
  • Inability to hear and understand instructions.

Brain Imaging Studies:

  • All standard MRI exclusion criteria, such as having any metallic objects in the body, or being too large to fit or operate comfortably in the scanner bore.

Sites / Locations

  • Smith-Kettlewell Eye Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blindness history

Arm Description

Since this is a regression analysis, all participants are assigned to the same Arm with blindness history and the demographics as covariates.

Outcomes

Primary Outcome Measures

Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints
The trajectory of the drawing hand while performing memory-guided navigational tasks will be electronically recorded for assessment of from Pre to Post1 change in terms of drawing speed in cm/s. Note: The three timepoints of the study are: Pre: Immediately before the 5-day Cognitive-Kinesthetic training period Post1: Immediately after the 5-day Cognitive-Kinesthetic training period Post2: Within 3-6 months after Post1, without any training intervening between Post1 and Post2 The time frames for changes and maintenance assessment are given as ranges to allow for scheduling logistics but represent a single interval per participant for each measure.
Maintenance of change in blind map drawing speed from Post1 to extended post-training (Post2) timepoints
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Post1 to Post2 change in drawing speed in cm/s.
Change in blind map drawing errors from Pre to Post1 timepoints
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Pre to Post1 change in navigation drawing errors in terms of number of incorrect turns.
Maintenance of change in blind map drawing errors from Post1 to Post2 timepoints
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Post1 to Post2 change in navigation drawing errors in terms of number of incorrect turns.
Change in total navigation time during blind macro-scale navigation of the shortest path from Pre to Post1 timepoints
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Pre to Post1 change in total navigation time in s.
Maintenance of change in number of total navigation time during blind navigation of the shortest path at macro-scale from Post1 to Post2 timepoints
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Post1 to Post2 change in terms of total navigation time measured in s.
Change in total number of contact errors during blind macro-scale navigation from Pre to Post1 timepoints
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Pre to Post1 change in terms of total number of contact errors.
Maintenance of change in total number of contact errors during blind macro-scale navigation from Post1 to Post2 timepoints
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Post1 to Post2 change in number of contact errors.
Change in functional MRI (fMRI) activation in the cortical navigation network
Whole-brain fMRI will be run to measure activation in the cortical navigation network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the cortical navigation network will be assessed from the Pre to Post1 timepoints in z-score units.
Maintenance of change in fMRI activation in the cortical navigation network
Whole-brain fMRI will be run to measure activation in the cortical navigation network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The maintenance in average activation in the cortical navigation network will be assessed from the Post1 to Post2 timepoints in z-score units.
Change in functional MRI (fMRI) activation in the spatial working memory network
Whole-brain fMRI will be run to measure activation in the spatial working memory network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the spatial working memory network will be assessed from the Pre to Post1 timepoints in z-score units.
Maintenance of change in fMRI activation in the spatial working memory network
Whole-brain fMRI will be run to measure activation in the spatial working memory network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the spatial working memory network will be assessed from the Post1 to Post2 timepoints in z-score units.
Change in Granger causal connectivity (GCC) density in the cortical navigation network
The changes of the GC connectivity density in the navigation network from the Pre to Post1 will be assessed in terms of the connectivity density index, defined as the ratio of the number of significant GC connections to the number of network nodes.
Maintenance of change in GCC density in the cortical navigation network
The changes of the GC connectivity density in the navigation network from the Post1 to Post2 will be assessed in terms of the connectivity density index, defined as the ratio of the number of significant GC connections to the number of network nodes.

Secondary Outcome Measures

Transfer of training to untrained spatio-cognitive abilities
The transfer of the training effect to untrained spatio-cognitive abilities will be assessed for a Pre to Post1 change in terms of the score on the Cognitive Test for the Blind (CTB) of the McCarron-Dial Comprehensive Vocational Evaluation System in its standardized IQ-style units.
Maintenance of transfer of training to untrained spatio-cognitive abilities
The maintenance of the training effect to untrained spatio-cognitive abilities will be assessed for a Post1 to Post2 change on the Cognitive Test for the Blind (CTB) of the McCarron-Dial Comprehensive Vocational Evaluation System measured in its standardized IQ-style units.
Change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
DTI will be used to assess the change in average voxelwise Fractional Anisotropy (FA) throughout the pathways of the cortical navigation network from the Pre to Post1 timepoints in FA z-score units.
Maintenance of change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
DTI will be used to assess the change in average voxelwise FA throughout the pathways of the cortical navigation network from the Post1 to Post2 timepoints in FA z-score units.
Change in mobility self-assessment
The Kuyk Mobility Function Questionnaire for blindness and profound visual impairment will be used to assess the change in effects of training on everyday mobility from the Pre to the Post2 timepoints in terms of its standardized score.

Full Information

First Posted
May 6, 2022
Last Updated
May 11, 2022
Sponsor
Smith-Kettlewell Eye Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05377853
Brief Title
Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
Official Title
Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith-Kettlewell Eye Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
One of the most challenging tasks for blind and visually impaired individuals is navigation through a complex environment. The goal of the present multidisciplinary study is to increase spatial-cognition abilities in people who are blind or visually impaired through training with the previously-developed Cognitive-Kinesthetic Rehabilitation Training to improve navigation, and to investigate the resultant neuroplastic brain reorganization through multimodal brain imaging. In accordance with National Eye Institute (NEI) strategic goals, this multidisciplinary project will promote the development of well-informed new approaches to navigational rehabilitation, memory enhancement and cross-modal brain plasticity to benefit 'cutting edge' fields of mobile assistive technologies, vision restoration and memory facilitation for the aging brain.
Detailed Description
The investigators propose a radical new multidisciplinary approach to navigation training in blindness and visual impairment. Successful navigation requires the development of an accurate and flexible mental, or cognitive, map of the navigational space and of the route trajectory required to travel from the current to the target location. The Cognitive-Kinesthetic (C-K) Rehabilitation Training that the PI has developed in the preceding period utilizes a unique form of blind memory-guided drawing to develop cognitive mapping to a high level of proficiency. Particular reliance must be placed on such mental maps (supported only by tactile and auditory inputs), and on the ability to use them effectively for spatiomotor control, when vision with its built-in spatial functionality is lost. There is, however, a fundamental gap in the practice of Orientation and Mobility (O&M), which is the lack of a specific emphasis on enhancement of these cognitive roots of spatiomotor activity, despite their known importance for navigation in the visually impaired. The investigators therefore propose a rigorous multidisciplinary approach to this issue, which lies at the intersection of the fields of spatiomotor rehabilitation, blindness assessment technologies, and brain function, each a focus of one Specific Aim. To train the spatial cognition abilities underlying successful navigation, the current proposal aims to translate the power of the C-K Rehabilitation Training to the domain of navigation. The blind and visually impaired trainees will quickly learn how to generate precise and stable cognitive maps of haptically explored raised-line images or tactile maps, and how to use the formed cognitive maps to confidently guide both drawing 'hand navigation' on a map-scale, and whole-body blind navigation on the macro-scale. Once translated to navigation, the preliminary data show that this efficient and enjoyable training will rapidly and sustainably enhance spatial cognition functions both for improved navigation performance and for enhancement of more general spatial cognitive skills. Beyond its practical advantages, the rapid and effective training protocol will also serve as an efficient tool to drive and study training-based neuroplasticity mechanisms through a comprehensive whole-brain multimodal brain imaging platform.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blindness, Blindness, Acquired, Low Vision, Blindness, Complete
Keywords
blindness, plasticity, spatial memory, training, navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple regression analyses with life history and vision-related clinical factors as covariates
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blindness history
Arm Type
Experimental
Arm Description
Since this is a regression analysis, all participants are assigned to the same Arm with blindness history and the demographics as covariates.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Kinesthetic Navigational Training
Intervention Description
Training with tactile maps to improve spatial memory capability for enhanced navigational capabilities.
Primary Outcome Measure Information:
Title
Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints
Description
The trajectory of the drawing hand while performing memory-guided navigational tasks will be electronically recorded for assessment of from Pre to Post1 change in terms of drawing speed in cm/s. Note: The three timepoints of the study are: Pre: Immediately before the 5-day Cognitive-Kinesthetic training period Post1: Immediately after the 5-day Cognitive-Kinesthetic training period Post2: Within 3-6 months after Post1, without any training intervening between Post1 and Post2 The time frames for changes and maintenance assessment are given as ranges to allow for scheduling logistics but represent a single interval per participant for each measure.
Time Frame
6-10 days
Title
Maintenance of change in blind map drawing speed from Post1 to extended post-training (Post2) timepoints
Description
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Post1 to Post2 change in drawing speed in cm/s.
Time Frame
3-6 months
Title
Change in blind map drawing errors from Pre to Post1 timepoints
Description
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Pre to Post1 change in navigation drawing errors in terms of number of incorrect turns.
Time Frame
6-10 days
Title
Maintenance of change in blind map drawing errors from Post1 to Post2 timepoints
Description
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Post1 to Post2 change in navigation drawing errors in terms of number of incorrect turns.
Time Frame
3-6 months
Title
Change in total navigation time during blind macro-scale navigation of the shortest path from Pre to Post1 timepoints
Description
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Pre to Post1 change in total navigation time in s.
Time Frame
6-10 days
Title
Maintenance of change in number of total navigation time during blind navigation of the shortest path at macro-scale from Post1 to Post2 timepoints
Description
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Post1 to Post2 change in terms of total navigation time measured in s.
Time Frame
3-6 months
Title
Change in total number of contact errors during blind macro-scale navigation from Pre to Post1 timepoints
Description
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Pre to Post1 change in terms of total number of contact errors.
Time Frame
6-10 days
Title
Maintenance of change in total number of contact errors during blind macro-scale navigation from Post1 to Post2 timepoints
Description
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Post1 to Post2 change in number of contact errors.
Time Frame
3-6 months
Title
Change in functional MRI (fMRI) activation in the cortical navigation network
Description
Whole-brain fMRI will be run to measure activation in the cortical navigation network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the cortical navigation network will be assessed from the Pre to Post1 timepoints in z-score units.
Time Frame
6-10 days
Title
Maintenance of change in fMRI activation in the cortical navigation network
Description
Whole-brain fMRI will be run to measure activation in the cortical navigation network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The maintenance in average activation in the cortical navigation network will be assessed from the Post1 to Post2 timepoints in z-score units.
Time Frame
3-6 months
Title
Change in functional MRI (fMRI) activation in the spatial working memory network
Description
Whole-brain fMRI will be run to measure activation in the spatial working memory network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the spatial working memory network will be assessed from the Pre to Post1 timepoints in z-score units.
Time Frame
6-10 days
Title
Maintenance of change in fMRI activation in the spatial working memory network
Description
Whole-brain fMRI will be run to measure activation in the spatial working memory network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the spatial working memory network will be assessed from the Post1 to Post2 timepoints in z-score units.
Time Frame
3-6 months
Title
Change in Granger causal connectivity (GCC) density in the cortical navigation network
Description
The changes of the GC connectivity density in the navigation network from the Pre to Post1 will be assessed in terms of the connectivity density index, defined as the ratio of the number of significant GC connections to the number of network nodes.
Time Frame
6-10 days
Title
Maintenance of change in GCC density in the cortical navigation network
Description
The changes of the GC connectivity density in the navigation network from the Post1 to Post2 will be assessed in terms of the connectivity density index, defined as the ratio of the number of significant GC connections to the number of network nodes.
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Transfer of training to untrained spatio-cognitive abilities
Description
The transfer of the training effect to untrained spatio-cognitive abilities will be assessed for a Pre to Post1 change in terms of the score on the Cognitive Test for the Blind (CTB) of the McCarron-Dial Comprehensive Vocational Evaluation System in its standardized IQ-style units.
Time Frame
6-10 days
Title
Maintenance of transfer of training to untrained spatio-cognitive abilities
Description
The maintenance of the training effect to untrained spatio-cognitive abilities will be assessed for a Post1 to Post2 change on the Cognitive Test for the Blind (CTB) of the McCarron-Dial Comprehensive Vocational Evaluation System measured in its standardized IQ-style units.
Time Frame
3-6 months
Title
Change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
Description
DTI will be used to assess the change in average voxelwise Fractional Anisotropy (FA) throughout the pathways of the cortical navigation network from the Pre to Post1 timepoints in FA z-score units.
Time Frame
6-10 days
Title
Maintenance of change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
Description
DTI will be used to assess the change in average voxelwise FA throughout the pathways of the cortical navigation network from the Post1 to Post2 timepoints in FA z-score units.
Time Frame
3-6 months
Title
Change in mobility self-assessment
Description
The Kuyk Mobility Function Questionnaire for blindness and profound visual impairment will be used to assess the change in effects of training on everyday mobility from the Pre to the Post2 timepoints in terms of its standardized score.
Time Frame
3-6 months
Other Pre-specified Outcome Measures:
Title
Age
Description
The covariate of age of the participants will be measured in years.
Time Frame
Pre-training timepoint
Title
Gender
Description
The covariate of gender of the participants will be measured in three categorical values (male, intermediate, female).
Time Frame
Pre-training timepoint.
Title
Current level of vision
Description
The covariate of current level of vision of the participants will be measured with the Bailey-Lovey eyechart in Snellen units.
Time Frame
Pre-training timepoint
Title
Age of onset of current level of vision
Description
The covariate of age of onset of the current level of vision across of the participant will be measured in years.
Time Frame
Pre-training timepoint
Title
Duration of full vision
Description
The covariate of duration of full vision of the participants will be measured in years.
Time Frame
Pre-training timepoint
Title
Duration of Orientation and Mobility (O&M) training
Description
The covariate of O&M training of the participants will be measured in years.
Time Frame
Pre-training timepoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Behavioral Studies: Vision from < 20/500 to NLP (No Light Perception) Brain Imaging Studies: Vision from < 20/500 to NLP Within average gender range for height +/-1 standard deviation Within average gender range for weight +/-1 standard deviation Comfortable with MRI procedures Exclusion Criteria: Behavioral Studies: Neurological deficits Inability to normally control lower or upper extremities Inability to hear and understand instructions. Brain Imaging Studies: All standard MRI exclusion criteria, such as having any metallic objects in the body, or being too large to fit or operate comfortably in the scanner bore.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lora T Likova
Phone
415 345 2066
Email
lora@ski.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher W Tyler
Phone
415 345 2020
Email
cwt@ski.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora T Likova
Organizational Affiliation
Senior Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smith-Kettlewell Eye Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lora T Likova, PhD
Phone
415-345-2066
Email
lora@ski.org
First Name & Middle Initial & Last Name & Degree
Christopher W Tyler, PhD
Phone
415 345 2020
Email
cwt@ski.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
33223582
Citation
Likova LT, Cacciamani L. Transfer of Learning in People Who Are Blind: Enhancement of Spatial-Cognitive Abilities Through Drawing. J Vis Impair Blind. 2018 Jul 1;112(4):385-397. doi: 10.1177/0145482x1811200405.
Results Reference
result
PubMed Identifier
34566588
Citation
Likova LT, Mineff KN, Nicholas SC. Mental Visualization in the Cerebellum: Rapid Non-motor Learning at Sub-Lobular and Causal Network Levels. Front Syst Neurosci. 2021 Sep 10;15:655514. doi: 10.3389/fnsys.2021.655514. eCollection 2021.
Results Reference
result
PubMed Identifier
23346061
Citation
Likova LT. A Cross-Modal Perspective on the Relationships between Imagery and Working Memory. Front Psychol. 2013 Jan 18;3:561. doi: 10.3389/fpsyg.2012.00561. eCollection 2012.
Results Reference
result
PubMed Identifier
28890944
Citation
Likova LT, Tyler CW, Cacciamani L, Mineff K, Nicholas S. The Cortical Network for Braille Writing in the Blind. IS&T Int Symp Electron Imaging. 2016;2016:10.2352/ISSN.2470-1173.2016.16.HVEI-095. doi: 10.2352/ISSN.2470-1173.2016.16.HVEI-095. Epub 2016 Feb 14.
Results Reference
result
PubMed Identifier
28347878
Citation
Cacciamani L, Likova LT. Memory-guided drawing training increases Granger causal influences from the perirhinal cortex to V1 in the blind. Neurobiol Learn Mem. 2017 May;141:101-107. doi: 10.1016/j.nlm.2017.03.013. Epub 2017 Mar 24.
Results Reference
result
PubMed Identifier
31633079
Citation
Likova LT, Mei M, Mineff KN, Nicholas SC. Learning face perception without vision: Rebound learning effect and hemispheric differences in congenital vs late-onset blindness. IS&T Int Symp Electron Imaging. 2019 Jan 13;2019:2371-23713. doi: 10.2352/ISSN.2470-1173.2019.12.HVEI-237.
Results Reference
result
PubMed Identifier
22593738
Citation
Likova LT. Drawing enhances cross-modal memory plasticity in the human brain: a case study in a totally blind adult. Front Hum Neurosci. 2012 May 14;6:44. doi: 10.3389/fnhum.2012.00044. eCollection 2012.
Results Reference
result

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Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment

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