An interventional study of Table Top Visual Intervention and Bioness Integrated Therapy System Visual Intervention in Stroke, Neurologic Disorder and Traumatic Brain Injury, sponsored by Gaylord Hospital, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Gaylord Hospital, Inc · Not applicable, Interventional, and Treatment
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.
The primary objective of this study is to demonstrate the effectiveness of a multi-session prescribed regimen involving the Bioness Integrated Therapy System (BITS) touch screen technology as a safe, practical, and beneficial means to increase visual field awareness for individuals with neurological vision field deficits receiving inpatient therapy. The overall goal is to determine if the use of BITS touch screen technology more effectively improves visual field awareness than conventional vision interventions involving table-top pen and paper activities.
Prior to consenting interested individuals, the presence of a visual field deficit will be confirmed through confrontation testing. Consented participants will perform an initial Bells Test assessment to determine initial visual field awareness. In addition to the Bells Test assessment, a Neuro-Optometrist/investigator will use a Kinetic Field Analyzer to perform a visual field test to measure the density of the field deficit, or blind-spot. Bells Test and Kinetic Field Analyzer testing will be conducted within 1 week of admission to the study (pre-assessment) and within 1 week prior to participant discharge (post-assessment).
Consented participants will be alternately assigned to either Group "A" or Group "B". Participants in Group A will be offered traditional vision interventions that will include word search, scanning activities, and saccade training. Participants in Group B will be prescribed and complete a BITS regimen with occupational therapist/investigator using the BITS programs of visual scanning, visual pursuits and/or visual motor. Participants in both groups will complete six, 20 minute, sessions over three-weeks. A convenience sample of 30 participants (15 per group) will be recruited; the enrollment period is expected to last approximately 12 months.
In addition to the visual intervention, all participants will be evaluated by the Neuro-Optometrist/investigator for the need of prismatic correction for field expansion therapy. Prismatic correction is customarily used by eye care professionals to correct ocular deviations and align the eyes to correct double vision. This correction uses unequal prismatic correction for each eye. Prismatic correction can also be used in equal powers for each eye that is often called "yoked" prismatic correction. Yoked prisms are often used with stroke patients since they can change the location of objects in space as well as have the ability to balance visual skews in spatial perception. These patients often present with hemianopic visual field deficits. The yoked prism allows areas that are not seen to be perceived by displacing the objects into the area of vision not blinded by the stroke as well as balancing visual-spatial perceptual impairments. In turn this treatment allows rehabilitative therapy to be more effective with better outcomes and is part of the standard of care. All participants will be evaluated and receive the appropriate prismatic correction as prescribed.
Data analysis: All data will be collected and analyzed in an unpaired fashion as appropriate; adjustments for abnormal distribution, unequal variance, and repeated measure will be applied as necessary. In the case of missing or inconsistent data due to early withdraw, early participant discharge, or other unforeseen events, the datasets will be evaluated as normal.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 37 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Gaylord Hospital, Inc is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Table Top 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.
Device: Bioness Integrated Therapy System Visual Intervention
Table top visual interventions and exercises.
Also known as: Group A; Analog; Table Top
Digital visual interventions and exercises.
Also known as: Group B; Digital; BITS
Bells Test
Used to determine initial visual field awareness. The participant is presented with a standardized pen and paper assessment that includes pictures of bells and other objects. The participant has to locate and circle as many bells as they can without circling any distractors. The participant is scored on the time that it takes to complete the assessment, the number of bells that are located on both the left and right side of the page, and the number of distractors that are located. The Bells test scored on a scale of 0 through 35; the higher the score the better.
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.
Kinetic Field Assessment - Field of View
Neuro-Optometrist delivered test. Measures the density or presence of field deficits, or blind-spots, in participants using moving objects with a fixed luminance and color. Each participant has both eyes assessed (n = 2). Measured in degrees from 0-360, typical values for healthy adults are 170-200 degrees.
Time frame: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.
Kinetic Field Testing - Visual Field Index
Neuro-Optometrist delivered test. Measures the density or presence of field deficits, or blind-spots, in participants using moving objects with a fixed luminance and color. Each participant has both eyes assessed (n = 2). Visual Field Index is a percentage from 0-100%, with 100% being a normal field and 0% being a perimetrically blind field.
Time frame: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.
| Milestone | Table Top Visual Intervention | Bioness Integrated Therapy System Visual Intervention |
|---|---|---|
| Started | 18 | 19 |
| Completed | 16 | 17 |
| Not completed | 2 | 2 |
Used to determine initial visual field awareness. The participant is presented with a standardized pen and paper assessment that includes pictures of bells and other objects. The participant has to locate and circle as many bells as they can without circling any distractors. The participant is scored on the time that it takes to complete the assessment, the number of bells that are located on both the left and right side of the page, and the number of distractors that are located. The Bells test scored on a scale of 0 through 35; the higher the score the better.
| Number of items correct | Pre-Assessment Tabletop | Post-Assessment Tabletop | Pre-Assessment BITS | Post-Assessment BITS |
|---|---|---|---|---|
| Bells Test | 14.2 (8.0 to 20.4) | 18.3 (12.8 to 23.7) | 19.3 (13.2 to 25.4) | 27.1 (22.4 to 31.7) |
Neuro-Optometrist delivered test. Measures the density or presence of field deficits, or blind-spots, in participants using moving objects with a fixed luminance and color. Each participant has both eyes assessed (n = 2). Measured in degrees from 0-360, typical values for healthy adults are 170-200 degrees.
| Degrees | Pre-Exam Tabletop | Post-Exam Tabletop | Pre-Exam BITS | Post-Exam BITS |
|---|---|---|---|---|
| Kinetic Field Assessment - Field of View | 117.68 ± 43.68 | 167 ± 49.38 | 125.56 ± 44.36 | 180.97 ± 34.78 |
Neuro-Optometrist delivered test. Measures the density or presence of field deficits, or blind-spots, in participants using moving objects with a fixed luminance and color. Each participant has both eyes assessed (n = 2). Visual Field Index is a percentage from 0-100%, with 100% being a normal field and 0% being a perimetrically blind field.
| Visual field index | Pre-Exam Tabletop | Post-Exam Tabletop | Pre-Exam BITS | Post-Exam BITS |
|---|---|---|---|---|
| Kinetic Field Testing - Visual Field Index | 38.96 ± 14.46 | 55.29 ± 16.35 | 41.58 ± 14.69 | 59.92 ± 11.52 |
Collected over Participants were assessed for adverse events during the course of enrollment in study activities, approximately 1 month from baseline to hospital discharge.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Table Top Visual Intervention | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Bioness Integrated Therapy System Visual Intervention | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | Table Top Visual Intervention | Bioness Integrated Therapy System Visual Intervention | Total |
|---|---|---|---|
| Mean | 63.1 ± 18.4 | 63.4 ± 13.6 | 63.2 ± 15.9 |
| Sex: Female, Male(Participants) | Table Top Visual Intervention | Bioness Integrated Therapy System Visual Intervention | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 7 | 9 | 16 |
| Race (NIH/OMB)(Participants) | Table Top Visual Intervention | Bioness Integrated Therapy System Visual Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 12 | 12 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Copies of the study protocol will be provided upon request. Requests for copies of the de-identified research data will be considered on a situational basis.
Ran from Jan 2021 to primary completion in Jun 2024, 41 months.
Results were first posted in Dec 2025, 1 year 6 months after primary completion.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 41 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Gaylord Hospital, Inc