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

NCT04930822 | Completed Results FDA Device

• 1 other identifier: 202005FAG
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Visual Field Cut; Visual Field Interventions; Visual Field Impairments; Hemianopsia; Quadrantanopia; Long Term Acute Care Hospital; Occupational Therapy; Activities of Daily Living; Visual Neglect; Visual Inattention; Hemi-inattention; Touch Screen Technology; Visual Scanning

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

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.

Other: Table Top Visual Intervention

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.

Device: Bioness Integrated Therapy System Visual Intervention

Interventions

Table Top Visual Intervention OTHER

Table top visual interventions and exercises.

Also known as: Group A; Analog; Table Top

Table Top Visual Intervention

Bioness Integrated Therapy System Visual Intervention DEVICE

Digital visual interventions and exercises.

Also known as: Group B; Digital; BITS

Bioness Integrated Therapy System Visual Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 18 years or older who are able to provide consent or have Power of Attorney (POA) able to consent.
• Must have an acute or subacute (diagnosed within the last 3 months) neurological diagnosis with a visual field deficit as verified by occupational therapist via confrontation testing.
• Admitted for inpatient rehabilitation
• Demonstrate the ability to follow 1 step directions
• Demonstrate sufficient upper extremity strength (as deemed appropriate by occupational therapist) to utilize BITS touch screen technology
• Ability to tolerate at least 30 minutes of intervention at a seated wheelchair level.

You may not qualify if:

• Severe cognitive impairments: Unable to follow one step directions, inability to communicate pain, or to stop intervention if needed
• Quadriparesis
• Previous significant visual impairment impacting visual fields or resulting in legal blindness in past medical history
• Re-admitted to Acute Care and do not return within 1 week
• Currently on a ventilator for respiratory support
• Unstable vital signs or deemed inappropriate to participate in therapy per Medical Staff
• Uncontrolled or new (within 24 hours) arrhythmias.
• Unresolved or new (within 24 hours) deep vein thrombosis.
• Concurrent severe neurological pathology/disease or stroke within 72 hours.
• Any reason the physician may deem as harmful to the participant to enroll or continue in the study.

Sponsors & Collaborators

• Gaylord Hospital, Inc: lead
• Connecticut Community Foundation: collaborator

Study Sites (1)

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

Related Publications (4)

• 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.

  PMID: 26156977 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

  BACKGROUND

• Goodwin D. Homonymous hemianopia: challenges and solutions. Clin Ophthalmol. 2014 Sep 22;8:1919-27. doi: 10.2147/OPTH.S59452. eCollection 2014.

  PMID: 25284978 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.

  BACKGROUND

Related Links

• Britannica. Visual Field Defect
• Visual Field Testing. Cleveland Clinic
• Visual Field Testing. American Academy of Ophthalmology

MeSH Terms

Conditions

Stroke; Nervous System Diseases; Brain Injuries, Traumatic; Brain Injuries; Hemianopsia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Henry Hrdlicka
• Organization: Gaylord Hospital

hhrdlicka@gaylord.org

2032842864

Study Officials

• Heidi Fagan, OTR/L

  Gaylord Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: January 8, 2021
• Primary Completion: June 12, 2024
• Study Completion: September 23, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)