Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness

Summary

The Bioness Integrated Therapy System (BITS) (Bioness Inc. Valencia, CA) Touch Screen is an FDA approved device comprised of an interactive touchscreen and diverse program options to challenge patients through the use of visual motor activities, visual and auditory processing, cognitive skills, and endurance training. The purpose of this study is to enroll a small group of adults currently undergoing inpatient rehabilitation, who were admitted for an acute neurological event and present with an acute neurological visual field impairment. The primary objective is to compare any increase in visual field awareness using a prescribed regimen consisting of conventional vision exercises compared with a regimen using BITS touch screen technology. Participants will be alternately assigned into "A" and "B" groups upon enrollment. The control group "A" will be prescribed conventional (table top, pen and paper) vision interventions provided by an occupational therapist and will receive pre- and post- assessment of visual field awareness. Treatment group "B" will include a prescribed regimen with use of BITS touch screen technology. Group B participants will receive the same pre- and post- assessment of visual field awareness as Group A participants. The hypothesis is that incorporation of the BITS touch screen technology, being more interactive, will result in better outcomes for visual field awareness. This is an unblinded quasi-randomized control trial that will determine best treatment intervention for visual field impairment. Safety will be measured by the number of reported adverse events. The study period will include 6 sessions per participant, conducted at one site, with the objective of enrolling at least 30 participants to have 15 participants in each study group.

Conditions

• Stroke
• Neurologic Disorder
• Traumatic Brain Injury
• Acquired Brain Injury

Interventions

OTHER

Table Top Visual Intervention

Table top visual interventions and exercises.

DEVICE

Bioness Integrated Therapy System Visual Intervention

Digital visual interventions and exercises.

Sponsors & Collaborators

• Connecticut Community Foundation

  collaborator UNKNOWN

• Gaylord Hospital, Inc

  lead OTHER

Principal Investigators

• Heidi Fagan, OTR/L · Gaylord Specialty Healthcare

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-08

Primary Completion

2024-06-12

Completion

2024-09-23

FDA Device

Yes

Countries

• United States

Study Locations