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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 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.

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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.

Interventions

  • OTHER Table Top Visual Intervention
  • DEVICE Bioness Integrated Therapy System Visual Intervention

Study Locations (1)

Connecticut

  • Gaylord Hospital - Wallingford

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2021-01-08
Est. Completion 2024-09-23
Phase NA

Sponsor

Gaylord Hospital

6 total trials

What the Registry Record Tells You About NCT04930822

The ClinicalTrials.gov registry entry for NCT04930822 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Gaylord Hospital, which has 6 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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