NCT04930822Completed
Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness
Does Bioness Integrated Therapy System (BITS) Touch Screen Technology Improve Field Awareness to Inpatients With Neurological Visual Field Deficits
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 11 Jun 2021
- Start date
- 8 Jan 2021
- Primary completion date
- 12 Jun 2024
- Lead sponsor
- Gaylord Hospital, Inc
- Diseases
- Stroke
- NCT number
- NCT04930822
What you commit to
- Study type: Interventional
- Participants enrolled: 37
- From 8 Jan 2021 to the primary completion date, 12 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous significant visual impairment impacting visual fields or resulting in legal blindness in past medical history
- Currently on a ventilator for respiratory support
- Unstable vital signs or deemed inappropriate to participate in therapy per Medical Staff
- Concurrent severe neurological pathology/disease or stroke within 72 hours.
Other illness
- Uncontrolled or new (within 24 hours) arrhythmias.
- Unresolved or new (within 24 hours) deep vein thrombosis.
Other
- Severe cognitive impairments: Unable to follow one step directions, inability to communicate pain, or to stop intervention if needed
- Quadriparesis
- Re-admitted to Acute Care and do not return within 1 week
- Any reason the physician may deem as harmful to the participant to enroll or continue in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gaylord Hospital Coordinator of this site? Confirm its status | Wallingford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.