StrokeNCT04930822
Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness
A study testing Table Top Visual Intervention and Bioness Integrated Therapy System Visual Intervention in people with Stroke and Neurologic Disorder, run by Gaylord Hospital, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Neurologic Disorder, Traumatic Brain Injury
- What is being tested?
- Table Top Visual Intervention and Bioness Integrated Therapy System Visual Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 23 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe cognitive impairments: Unable to follow one step directions, inability to communicate pain, or to stop intervention if needed
- Quadriparesis
- Previous significant visual impairment impacting visual fields or resulting in legal blindness in past medical history
- Re-admitted to Acute Care and do not return within 1 week
- Currently on a ventilator for respiratory support
- Unstable vital signs or deemed inappropriate to participate in therapy per Medical Staff
Show all 10Show fewer
- Uncontrolled or new (within 24 hours) arrhythmias.
- Unresolved or new (within 24 hours) deep vein thrombosis.
- Concurrent severe neurological pathology/disease or stroke within 72 hours.
- Any reason the physician may deem as harmful to the participant to enroll or continue in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Bioness Integrated Therapy System (BITS) Touch Screen Technology Improve Field Awareness to Inpatients With Neurological Visual Field Deficits
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.
Read the detailed description
The primary objective of this study is to demonstrate the effectiveness of a multi-session prescribed regimen involving the Bioness Integrated Therapy System (BITS) touch screen technology as a safe, practical, and beneficial means to increase visual field awareness for individuals with neurological vision field deficits receiving inpatient therapy. The overall goal is to determine if the use of BITS touch screen technology more effectively improves visual field awareness than conventional vision interventions involving table-top pen and paper activities.
Prior to consenting interested individuals, the presence of a visual field deficit will be confirmed through confrontation testing. Consented participants will perform an initial Bells Test assessment to determine initial visual field awareness. In addition to the Bells Test assessment, a Neuro-Optometrist/investigator will use a Kinetic Field Analyzer to perform a visual field test to measure the density of the field deficit, or blind-spot. Bells Test and Kinetic Field Analyzer testing will be conducted within 1 week of admission to the study (pre-assessment) and within 1 week prior to participant discharge (post-assessment).
Consented participants will be alternately assigned to either Group "A" or Group "B". Participants in Group A will be offered traditional vision interventions that will include word search, scanning activities, and saccade training. Participants in Group B will be prescribed and complete a BITS regimen with occupational therapist/investigator using the BITS programs of visual scanning, visual pursuits and/or visual motor. Participants in both groups will complete six, 20 minute, sessions over three-weeks. A convenience sample of 30 participants (15 per group) will be recruited; the enrollment period is expected to last approximately 12 months.
In addition to the visual intervention, all participants will be evaluated by the Neuro-Optometrist/investigator for the need of prismatic correction for field expansion therapy. Prismatic correction is customarily used by eye care professionals to correct ocular deviations and align the eyes to correct double vision. This correction uses unequal prismatic correction for each eye. Prismatic correction can also be used in equal powers for each eye that is often called "yoked" prismatic correction. Yoked prisms are often used with stroke patients since they can change the location of objects in space as well as have the ability to balance visual skews in spatial perception. These patients often present with hemianopic visual field deficits. The yoked prism allows areas that are not seen to be perceived by displacing the objects into the area of vision not blinded by the stroke as well as balancing visual-spatial perceptual impairments. In turn this treatment allows rehabilitative therapy to be more effective with better outcomes and is part of the standard of care. All participants will be evaluated and receive the appropriate prismatic correction as prescribed.
Data analysis: All data will be collected and analyzed in an unpaired fashion as appropriate; adjustments for abnormal distribution, unequal variance, and repeated measure will be applied as necessary. In the case of missing or inconsistent data due to early withdraw, early participant discharge, or other unforeseen events, the datasets will be evaluated as normal.
- Being tested
- Table Top Visual Intervention, Bioness Integrated Therapy System Visual Intervention
- Keywords
- Visual Field Cut, Visual Field Interventions, Visual Field Impairments, Hemianopsia, Quadrantanopia, Long Term Acute Care Hospital, Occupational Therapy, Activities of Daily Living, Visual Neglect, Visual Inattention, Hemi-inattention, Touch Screen Technology, Visual Scanning
- Medical subject headings
- Stroke, Nervous System Diseases, Brain Injuries, Traumatic, Brain Injuries, Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Table Top Visual InterventionOther
Also called Group A; Analog; Table Top
Table top visual interventions and exercises.
Bioness Integrated Therapy System Visual InterventionDevice
Also called Group B; Digital; BITS
Digital visual interventions and exercises.
| Study group | Role | What they receive |
|---|---|---|
| Table Top Visual Intervention | Active comparator | 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. Receives: Other: Table Top Visual Intervention |
| Bioness Integrated Therapy System Visual Intervention | Experimental | 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. Receives: Device: Bioness Integrated Therapy System Visual Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bells Test
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.
Measured: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge, approximately 1 month from baseline.
Kinetic Field Assessment - 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.
Measured: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.
Kinetic Field Testing - Visual Field Index
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.
Measured: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Jan 2021
- Primary completion12 Jun 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned into "A" and "B" groups upon admission in alternating fashion. 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.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaylord Hospital, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Connecticut Community Foundation
- Responsible party
- Sponsor
- Investigators
- Heidi Fagan, OTR/L, Principal investigator, Gaylord Specialty Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930822
- Sponsor's protocol ID
- 202005FAG
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2021
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Copies of the study protocol will be provided upon request. Requests for copies of the de-identified research data will be considered on a situational basis.
Publications
Master CL, Scheiman M, Gallaway M, Goodman A, Robinson RL, Master SR, Grady MF. Vision Diagnoses Are Common After Concussion in Adolescents. Clin Pediatr (Phila). 2016 Mar;55(3):260-7. doi: 10.1177/0009922815594367. Epub 2015 Jul 7.
PubMed 26156977Sara Stephenson, Alice Anderson-Tome, Sarah Fischer, Abby Guzman, William Meredith, Chandler Somers; Pilot Study: Using the Bioness Integrated Therapy System (BITS) To Examine the Correlation Between Skills and Success With On-the-Road Driving Evaluations. Am J Occup Ther 2019;73(4_Supplement_1):7311515280. https://doi.org/10.5014/ajot.2019.73S1-PO4054
Goodwin D. Homonymous hemianopia: challenges and solutions. Clin Ophthalmol. 2014 Sep 22;8:1919-27. doi: 10.2147/OPTH.S59452. eCollection 2014.
PubMed 25284978Gauthier L, Dehaut F, Joanette Y. The Bells Test: A quantitative and qualitative test for visual neglect. International Journal of Clinical Neuropsychology. US: MelNic Press, Inc.; 1989;11(2):49-54.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bioness Integrated Therapy System (BITS) Touch Screen Technology Improve Field Awareness to Inpatients With Neurological Visual Field Deficits
- ClinicalTrials.gov ID
- NCT04930822
- Acronym / sponsor ID
- 202005FAG
- Keywords
- Visual Field Cut, Visual Field Interventions, Visual Field Impairments, Hemianopsia, Quadrantanopia, Long Term Acute Care Hospital, Occupational Therapy, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Gaylord Hospital, IncUniversity, hospital or other
- Collaborators
- Connecticut Community Foundation
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to demonstrate the effectiveness of a multi-session prescribed regimen involving the Bioness Integrated Therapy System (BITS) touch screen technology as a safe, practical, and beneficial means to increase visual field awareness for individuals with neurological vision field deficits receiving inpatient therapy. The overall goal is to determine if the use of BITS touch screen technology more effectively improves visual field awareness than conventional vision interventions involving table-top pen and paper activities.
Prior to consenting interested individuals, the presence of a visual field deficit will be confirmed through confrontation testing. Consented participants will perform an initial Bells Test assessment to determine initial visual field awareness. In addition to the Bells Test assessment, a Neuro-Optometrist/investigator will use a Kinetic Field Analyzer to perform a visual field test to measure the density of the field deficit, or blind-spot. Bells Test and Kinetic Field Analyzer testing will be conducted within 1 week of admission to the study (pre-assessment) and within 1 week prior to participant discharge (post-assessment).
Consented participants will be alternately assigned to either Group "A" or Group "B". Participants in Group A will be offered traditional vision interventions that will include word search, scanning activities, and saccade training. Participants in Group B will be prescribed and complete a BITS regimen with occupational therapist/investigator using the BITS programs of visual scanning, visual pursuits and/or visual motor. Participants in both groups will complete six, 20 minute, sessions over three-weeks. A convenience sample of 30 participants (15 per group) will be recruited; the enrollment period is expected to last approximately 12 months.
In addition to the visual intervention, all participants will be evaluated by the Neuro-Optometrist/investigator for the need of prismatic correction for field expansion therapy. Prismatic correction is customarily used by eye care professionals to correct ocular deviations and align the eyes to correct double vision. This correction uses unequal prismatic correction for each eye. Prismatic correction can also be used in equal powers for each eye that is often called "yoked" prismatic correction. Yoked prisms are often used with stroke patients since they can change the location of objects in space as well as have the ability to balance visual skews in spatial perception. These patients often present with hemianopic visual field deficits. The yoked prism allows areas that are not seen to be perceived by displacing the objects into the area of vision not blinded by the stroke as well as balancing visual-spatial perceptual impairments. In turn this treatment allows rehabilitative therapy to be more effective with better outcomes and is part of the standard of care. All participants will be evaluated and receive the appropriate prismatic correction as prescribed.
Data analysis: All data will be collected and analyzed in an unpaired fashion as appropriate; adjustments for abnormal distribution, unequal variance, and repeated measure will be applied as necessary. In the case of missing or inconsistent data due to early withdraw, early participant discharge, or other unforeseen events, the datasets will be evaluated as normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned into "A" and "B" groups upon admission in alternating fashion. 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.
| Arm | Type | Receives |
|---|---|---|
| Table Top Visual Intervention | Active comparator | Other: Table Top Visual InterventionInterventions 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. |
| Bioness Integrated Therapy System Visual Intervention | Experimental | Device: Bioness Integrated Therapy System Visual InterventionIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Severe cognitive impairments: Unable to follow one step directions, inability to communicate pain, or to stop intervention if needed
- Quadriparesis
- Previous significant visual impairment impacting visual fields or resulting in legal blindness in past medical history
- Re-admitted to Acute Care and do not return within 1 week
- Currently on a ventilator for respiratory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Table Top Visual InterventionAlso: Group A; Analog; Table TopTable top visual interventions and exercises. | Other | Table Top Visual Intervention |
| Bioness Integrated Therapy System Visual InterventionAlso: Group B; Digital; BITSDigital visual interventions and exercises. | Device | Bioness Integrated Therapy System Visual Intervention |
Primary outcome
Bells Test
Time frame: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge, approximately 1 month from baseline.
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.
Kinetic Field Assessment - Field of View
Time frame: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.
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.
Kinetic Field Testing - Visual Field Index
Time frame: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26156977Master CL, Scheiman M, Gallaway M, Goodman A, Robinson RL, Master SR, Grady MF. Vision Diagnoses Are Common After Concussion in Adolescents. Clin Pediatr (Phila). 2016 Mar;55(3):260-7. doi: 10.1177/0009922815594367. Epub 2015 Jul 7.
- BackgroundSara Stephenson, Alice Anderson-Tome, Sarah Fischer, Abby Guzman, William Meredith, Chandler Somers; Pilot Study: Using the Bioness Integrated Therapy System (BITS) To Examine the Correlation Between Skills and Success With On-the-Road Driving Evaluations. Am J Occup Ther 2019;73(4_Supplement_1):7311515280. https://doi.org/10.5014/ajot.2019.73S1-PO4054
- Background: PubMed 25284978Goodwin D. Homonymous hemianopia: challenges and solutions. Clin Ophthalmol. 2014 Sep 22;8:1919-27. doi: 10.2147/OPTH.S59452. eCollection 2014.
- BackgroundGauthier L, Dehaut F, Joanette Y. The Bells Test: A quantitative and qualitative test for visual neglect. International Journal of Clinical Neuropsychology. US: MelNic Press, Inc.; 1989;11(2):49-54.
- Visual Field Testing. Cleveland ClinicLink provided by the sponsor.
- Visual Field Testing. American Academy of OphthalmologyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Copies of the study protocol will be provided upon request. Requests for copies of the de-identified research data will be considered on a situational basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Fagan, OTR/L principal investigator
Gaylord Specialty Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Table Top Visual Intervention and Bioness Integrated Therapy System Visual Intervention in people with Stroke and Neurologic Disorder, run by Gaylord Hospital, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bells Test (time frame: Pre and post tests will be collected within 1 week following enrollment and within 1 week prior to discharge, approximately 1 month from baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04930822, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.