Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision

Study Overview
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Brief Summary
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This research is aimed to address one of the big gaps in the current vision rehabilitation protocols for people with profound visual impairment by evaluating a multisensory approach. There are a growing number of clinical trials that recruit people with end-stage eye diseases and the rehabilitation plan following various treatments is not clear. It is important to address this in order to maximize the efficacy of such treatments and to improve the quality of life in people with profound visual impairment.

Official Title
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Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision

Conditions
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Low Vision Blindness, Visual Impairment, Quality of Life, Functional Visual Loss

Intervention / Treatment
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* Behavioral: Visual Information Training
* Behavioral: Multimodal training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with ultra low vision (visual acuity ≤20/1600) Exclusion Criteria: <12 years of age dependent on sighted guide cognitive impairment

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual Information Training<br> | Behavioral: Visual Information Training<br>* Participants in this arm will receive training to improve the use of residual vision to enhance functional performance.<br>|
| Experimental: Multimodal Training<br> | Behavioral: Multimodal training<br>* Participants in this arm will receive training in integrating input from different senses to enhance functional performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual ability | Change in visual ability as measured by the Ultra Low Vision Visual Function Questionnaire. The scale measures both visual ability (Person Measure) and difficulty (Item Measure) in people with ultra low vision. 150 items on a likert scale ranging from 1 impossible, to 4 not difficult. Using a Rasch-Andrich rating model, Person Measures range from -6 to +2.8 logits, Item Measures range from -3.3 to +3.0 logits. Higher scores indicating better outcome. | Baseline, 1 month, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hand-eye coordination | Change in hand eye coordination as assessed by a leap motion (Ultra Leap) sensor taped to a Virtual Reality headset to track hand eye coordination. | Baseline, 1 month, 3 months, 6 months | 
| Change in hearing ability | Change in hearing ability as assessed by iHEARtest device (earphones, computer application). The participant presses the space bar on their computer keyboard every time they hear a sound. The iHEARtest provides a Hearing Number™ in each ear on a scale from 1=profound impairment, to 5= no impairment. | Baseline, 1 month, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultra low vision rehabilitation, multi sensory, functional vision assessment