Trial Outcomes & Findings for Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness (NCT NCT04930822)

Last Updated: 2025-12-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge, approximately 1 month from baseline.

Results posted on

2025-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	18	19
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Table Top Visual Intervention n=16 Participants 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.	Bioness Integrated Therapy System Visual Intervention n=17 Participants 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.	Total n=33 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 18.4 • n=68 Participants	63.4 years STANDARD_DEVIATION 13.6 • n=4 Participants	63.2 years STANDARD_DEVIATION 15.9 • n=219 Participants
Sex: Female, Male Female	9 Participants n=68 Participants	8 Participants n=4 Participants	17 Participants n=219 Participants
Sex: Female, Male Male	7 Participants n=68 Participants	9 Participants n=4 Participants	16 Participants n=219 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Asian	2 Participants n=68 Participants	3 Participants n=4 Participants	5 Participants n=219 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Black or African American	2 Participants n=68 Participants	2 Participants n=4 Participants	4 Participants n=219 Participants
Race (NIH/OMB) White	12 Participants n=68 Participants	12 Participants n=4 Participants	24 Participants n=219 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants

PRIMARY outcome

Timeframe: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge, approximately 1 month from baseline.

Population: Number of total items correct

Outcome measures

Outcome measures
Measure	Pre-Assessment Tabletop n=16 Participants Bells test score prior to intervention	Post-Assessment Tabletop n=16 Participants Bells test score post intervention	Pre-Assessment BITS n=17 Participants Bells test score prior to intervention	Post-Assessment BITS n=17 Participants Bells test score post intervention
Bells Test	14.2 Number of items correct Interval 8.0 to 20.4	18.3 Number of items correct Interval 12.8 to 23.7	19.3 Number of items correct Interval 13.2 to 25.4	27.1 Number of items correct Interval 22.4 to 31.7

PRIMARY outcome

Timeframe: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.

Population: Total 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.

Outcome measures

Outcome measures
Measure	Pre-Assessment Tabletop n=25 Eyes Bells test score prior to intervention	Post-Assessment Tabletop n=25 Eyes Bells test score post intervention	Pre-Assessment BITS n=32 Eyes Bells test score prior to intervention	Post-Assessment BITS n=32 Eyes Bells test score post intervention
Kinetic Field Assessment - Field of View	117.68 Degrees Standard Deviation 43.68	167 Degrees Standard Deviation 49.38	125.56 Degrees Standard Deviation 44.36	180.97 Degrees Standard Deviation 34.78

PRIMARY outcome

Timeframe: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.

Population: Visual Field Index = \[(Kinetic field measurement) / (normative value)\] \* 100

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.

Outcome measures

Outcome measures
Measure	Pre-Assessment Tabletop n=25 Eyes Bells test score prior to intervention	Post-Assessment Tabletop n=25 Eyes Bells test score post intervention	Pre-Assessment BITS n=32 Eyes Bells test score prior to intervention	Post-Assessment BITS n=32 Eyes Bells test score post intervention
Kinetic Field Testing - Visual Field Index	38.96 Visual field index Standard Deviation 14.46	55.29 Visual field index Standard Deviation 16.35	41.58 Visual field index Standard Deviation 14.69	59.92 Visual field index Standard Deviation 11.52

Adverse Events

Table Top Visual Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bioness Integrated Therapy System Visual Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Henry Hrdlicka

Gaylord Hospital

Phone: 2032842864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place