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

Part of paid clinical trials in Wallingford, Connecticut.

Sponsor
Gaylord Hospital, Inc
Study ID
NCT04930822
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Table Top Visual Intervention — OTHER
    Table top visual interventions and exercises.
  • Bioness Integrated Therapy System Visual Intervention — DEVICE
    Digital visual interventions and exercises.

Study Details

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.

Key Dates

Start date
Jan 8, 2021
Status verified
Dec 2025
Primary completion
Jun 12, 2024
Completion
Sep 23, 2024

Study Design

Enrollment
37 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Table Top Visual Intervention
    Interventions will include six, 20 minute sessions using pen and paper word search, scanning activities, and saccade visual training. All activities will be conducted with an occupational therapist/investigator.
  • Experimental: Bioness Integrated Therapy System Visual Intervention
    Intervention will includes six sessions using the Bioness Integrated Therapy System for 20 minutes using the programs of visual scanning, visual pursuits and/or visual motor.All activities will be conducted with an occupational therapist/investigator.

Primary Outcome Measure

Bells Test [ Time Frame: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge, approximately 1 month from baseline. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Gaylord HospitalWallingfordConnecticut06492-

Find similar trials in Wallingford, CT

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Gaylord Hospital· Wallingford, CT

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