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

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05028712

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Vision Blindness Visual Impairment Quality of Life Functional Visual Loss	Behavioral: Visual Information Training Behavioral: Multimodal training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Visual Information Training

Behavioral: Visual Information Training

Participants in this arm will receive training to improve the use of residual vision to enhance functional performance.

Experimental: Multimodal Training

Behavioral: Multimodal training

Participants in this arm will receive training in integrating input from different senses to enhance functional performance.

Outcome Measures

Primary Outcome Measures

Change in visual ability [Baseline, 1 month, 3 months, 6 months]
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.

Secondary Outcome Measures

Change in hand-eye coordination [Baseline, 1 month, 3 months, 6 months]
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.
Change in hearing ability [Baseline, 1 month, 3 months, 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

People with ultra low vision (visual acuity ≤20/1600)

Exclusion Criteria:

<12 years of age
dependent on sighted guide
cognitive impairment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Arathy Kartha, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT05028712

Other Study ID Numbers:

IRB00290776

First Posted:

Aug 31, 2021

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Johns Hopkins University

ultra low vision rehabilitation

multi sensory

functional vision assessment

Additional relevant MeSH terms:

Vision Disorders

Vision, Low

Blindness

Study Results

No Results Posted as of Aug 25, 2022