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| Name | Class |
|---|---|
| Connecticut Community Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Table Top Visual Intervention | Active Comparator | 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. |
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| Bioness Integrated Therapy System Visual Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Table Top Visual Intervention | Other | Table top visual interventions and exercises. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Fagan, OTR/L | Gaylord Specialty Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaylord Hospital | Wallingford | Connecticut | 06492 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26156977 | Background | Master CL, Scheiman M, Gallaway M, Goodman A, Robinson RL, Master SR, Grady MF. Vision Diagnoses Are Common After Concussion in Adolescents. Clin Pediatr (Phila). 2016 Mar;55(3):260-7. doi: 10.1177/0009922815594367. Epub 2015 Jul 7. | |
| Background | Sara Stephenson, Alice Anderson-Tome, Sarah Fischer, Abby Guzman, William Meredith, Chandler Somers; Pilot Study: Using the Bioness Integrated Therapy System (BITS) To Examine the Correlation Between Skills and Success With On-the-Road Driving Evaluations. Am J Occup Ther 2019;73(4_Supplement_1):7311515280. https://doi.org/10.5014/ajot.2019.73S1-PO4054 | ||
| 25284978 |
| Label | URL |
|---|---|
| Britannica. Visual Field Defect | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Table Top Visual Intervention: Table top visual interventions and exercises. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2025 |
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Participants will be assigned into "A" and "B" groups upon admission in alternating fashion. 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.
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| Bioness Integrated Therapy System Visual Intervention | Device | Digital visual interventions and exercises. |
|
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| Background |
| Goodwin D. Homonymous hemianopia: challenges and solutions. Clin Ophthalmol. 2014 Sep 22;8:1919-27. doi: 10.2147/OPTH.S59452. eCollection 2014. |
| Background | Gauthier L, Dehaut F, Joanette Y. The Bells Test: A quantitative and qualitative test for visual neglect. International Journal of Clinical Neuropsychology. US: MelNic Press, Inc.; 1989;11(2):49-54. |
| Visual Field Testing. Cleveland Clinic | View source |
| Visual Field Testing. American Academy of Ophthalmology | View source |
| 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. Bioness Integrated Therapy System Visual Intervention: Digital visual interventions and exercises. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Table Top Visual Intervention: Table top visual interventions and exercises. |
| BG001 | 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. Bioness Integrated Therapy System Visual Intervention: Digital visual interventions and exercises. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of total items correct | Posted | Mean | 95% Confidence Interval | Number of items correct | Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge, approximately 1 month from baseline. |
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| Primary | 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. | Total Field of View | Posted | Mean | Standard Deviation | Degrees | Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge. | Eyes | Eyes |
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| Primary | 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. | Visual Field Index = [(Kinetic field measurement) / (normative value)] * 100 | Posted | Mean | Standard Deviation | Visual field index | Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge. | Eyes | Eyes |
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Participants were assessed for adverse events during the course of enrollment in study activities, approximately 1 month from baseline to hospital discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Table Top Visual Intervention: Table top visual interventions and exercises. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | 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. Bioness Integrated Therapy System Visual Intervention: Digital visual interventions and exercises. | 0 | 17 | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Henry Hrdlicka | Gaylord Hospital | 2032842864 | hhrdlicka@gaylord.org |
| Nov 13, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009422 | Nervous System Diseases |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D006423 | Hemianopsia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D001766 | Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| ANOVA |
| 0.0219 |
Fisher's LSD utilized; no corrections for multiple comparisons |
| Predicted least squares mean difference |
| -8.809 |
| 2-Sided |
| 95 |
| -16.30 |
| -1.317 |
| Superiority |
| Alpha set at 0.05 | ANOVA | 0.0139 | Fisher's LSD utilized; no corrections for multiple comparisons | Predicted least squares mean difference | -4.063 | 2-Sided | 95 | -7.240 | -0.8849 | Superiority |
| Alpha set at 0.05 | ANOVA | <0.0001 | Fisher's LSD utilized; no corrections for multiple comparisons | Predicted least squares mean difference | -7.765 | 2-Sided | 95 | -10.85 | -4.682 | Superiority |
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Post intervention kinetic field test administered by a neuro-optometrist.
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