Trial results for a study evaluating the Bioness Integrated Therapy System (BITS) Touch Screen to improve field awareness in patients with neurological events were posted on ClinicalTrials.gov on 2025-12-23, with 37 participants enrolled.
Background
Stroke, traumatic brain injury, and other neurological disorders can often lead to visual field impairments, significantly impacting a patient's independence and quality of life. These impairments can manifest as reduced peripheral vision, neglect, or difficulty processing visual information, making daily tasks challenging. Rehabilitation efforts frequently focus on restoring or compensating for these deficits. The Bioness Integrated Therapy System (BITS) Touch Screen is an FDA-approved device designed to engage patients through visual motor activities, visual and auditory processing, cognitive skills, and endurance training, aiming to improve functional outcomes in rehabilitation settings.
Trial design
This completed study, designated as Phase NA, enrolled 37 participants undergoing inpatient rehabilitation following an acute neurological event. The conditions investigated included Stroke, Neurologic Disorder, Traumatic Brain Injury, and Acquired Brain Injury, specifically in individuals presenting with an acute neurological visual field impairment. The study's primary objective was to compare increases in visual field awareness using the BITS Touch Screen technology.
Key results
The trial reported several key measurements related to visual field awareness and function:
- Bells Test (Number of items correct):
- Pre-Assessment Tabletop mean: 14.2
- Post-Assessment Tabletop mean: 18.3
- Pre-Assessment BITS mean: 19.3
- Post-Assessment BITS mean: 27.1
- Kinetic Field Assessment - Field of View (Degrees):
- Pre-Exam Tabletop mean: 117.68 (Standard Deviation 43.68)
- Post-Exam Tabletop mean: 167 (Standard Deviation 49.38)
- Pre-Exam BITS mean: 125.56 (Standard Deviation 44.36)
- Post-Exam BITS mean: 180.97 (Standard Deviation 34.78)
- Kinetic Field Testing - Visual Field Index (Visual field index):
- Pre-Exam Tabletop mean: 38.96 (Standard Deviation 14.46)
- Post-Exam Tabletop mean: 55.29 (Standard Deviation 16.35)
- Pre-Exam BITS mean: 41.58 (Standard Deviation 14.69)
- Post-Exam BITS mean: 59.92 (Standard Deviation 11.52)
Further statistical analyses using ANOVA (Alpha set at 0.05) indicated:
- A predicted least squares mean difference of -5.107 (95.0% Confidence Interval: -12.6 to 2.385) with a p-value of 0.1779.
- A predicted least squares mean difference of -8.809 (95.0% Confidence Interval: -16.3 to -1.317) with a p-value of 0.0219.
- A predicted least squares mean difference of -4.063 (95.0% Confidence Interval: -7.24 to -0.8849) with a p-value of 0.0139.
- A predicted least squares mean difference of -7.765 (95.0% Confidence Interval: -10.85 to -4.682) with a p-value of 0.0001.
- A predicted least squares mean difference of -7.883 (95.0% Confidence Interval: -30.59 to 14.83) with a p-value of 0.493.
- A predicted least squares mean difference of -13.97 (95.0% Confidence Interval: -36.68 to 8.744) with a p-value of 0.2255.
What this means
The results suggest that the Bioness Integrated Therapy System (BITS) Touch Screen may contribute to improvements in visual field awareness and related cognitive functions in patients undergoing rehabilitation for neurological events like stroke. Across various measures such as the Bells Test, Kinetic Field Assessment, and Visual Field Index, post-intervention scores for the BITS group generally showed higher mean values compared to pre-intervention scores and, in some cases, greater improvements than traditional tabletop assessments. The statistical analyses indicate some significant differences, particularly in certain predicted least squares mean differences, suggesting a potential benefit of the BITS intervention in enhancing visual field awareness. These findings, from a small cohort of 37 participants, provide preliminary evidence for the utility of interactive touchscreen technology in neurological rehabilitation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04930822, titled "Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness", were posted on 2025-12-23 on clinicaltrials.gov.