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NCT04930822 · ClinicalTrials.gov registry record · NA
Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness
A NA study of Stroke and Traumatic Brain Injury, sponsored by Gaylord Hospital.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04930822: Completed NA study of Stroke and Traumatic Brain Injury, sponsored by Gaylord Hospital.
NCT04930822 is a NA study of Stroke and Traumatic Brain Injury that has completed, run by Gaylord Hospital. The registered enrollment target is 37 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04930822, a NA study of Stroke and Traumatic Brain Injury, has completed, sponsored by Gaylord Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Table Top Visual Intervention
- DEVICE Bioness Integrated Therapy System Visual Intervention
Study Locations (1)
Connecticut
- Gaylord Hospital - Wallingford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-01-08 |
| Est. Completion | 2024-09-23 |
| Phase | NA |
What the finished NCT04930822 record still lists
NCT04930822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Table Top Visual Intervention is the first listed.
NCT04930822 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04930822 about?
NCT04930822 is a clinical study titled "Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness". 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 ...
What is the current status of trial NCT04930822?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2021-01-08. Estimated completion is 2024-09-23.
What conditions does trial NCT04930822 study?
This clinical trial studies the following conditions: Stroke, Traumatic Brain Injury, Neurologic Disorder, Acquired Brain Injury.
What interventions are being tested in trial NCT04930822?
The interventions under investigation include: Table Top Visual Intervention (OTHER), Bioness Integrated Therapy System Visual Intervention (DEVICE).
Who is sponsoring clinical trial NCT04930822?
This trial is sponsored by Gaylord Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04930822 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04930822's enrollment target sits among peer trials
37 279th of 454 higher than 174 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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