- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07475611
Effectiveness of an Interactive Screen in the Rehabilitation of Neglect in Adults With Subacute Stroke: A Randomized Controlled Trial in Argentina.
Hemispatial neglect is one of the most frequent and disabling sequelae after a stroke, particularly following right-hemisphere lesions. Its prevalence ranges from 25% to 80% and is associated with poorer functional outcomes, increased risk of falls, prolonged hospital stays, and lower rates of discharge to home. In response to these challenges, rehabilitation technologies have emerged as promising tools, especially during the subacute phase of stroke, a critical period for neuroplasticity. The MYRO® device-an adjustable interactive screen that enables intensive, task-oriented training-has shown benefits in promoting visual scanning, midline crossing, and sensorimotor integration through personalized exercises with constant feedback.
This study aims to evaluate the effectiveness of MYRO® combined with conventional occupational therapy in patients with left hemispatial neglect secondary to subacute stroke. A randomized clinical trial will be conducted with 30 participants assigned to two groups: conventional occupational therapy (OT-C) and occupational therapy plus rehabilitation technology using MYRO® (OT-M). Both groups will receive interventions for four weeks, with assessments at baseline, at the end of the protocol, and at a six-week follow-up. Outcome measures will include the NIHSS, FIM, Catherine Bergego Scale, Cancelation Bells Test, and Line Bisection Test.
It is expected that the use of MYRO® will enhance visuospatial attention toward the left hemifield and accelerate functional recovery compared with conventional treatment alone. The results could provide relevant evidence supporting the integration of interactive technology into neurofunctional rehabilitation within the Argentine context.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Escobar
-
Buenos Aires, Escobar, Argentina, 1625
- FLENI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Right-sided stroke. Ischemic or hemorrhagic.
- Currently in the subacute phase of recovery from the event (1 week to <6 months post-stroke).
- Presence of left hemineglect as determined by the Catherine Bergego Scale and/or Cancel Bells Test and/or Line Bisection Test.
- Age 18 to 88 years.
- Native Spanish speaker.
Exclusion Criteria:
- Bilateral stroke. Previous strokes.
- Medically unstable condition.
- Previous visual impairments that prevent interaction with the device screen.
- Presence of severe left homonymous hemianopsia. Determined by the total absence of vision in the entire left visual field, evaluated by confrontation visual field testing during the neurological physical examination.
- Severe aphasia that prevents the comprehension of simple instructions that guarantee the completion of the task, determined by an NIHSS scale with a score of 3 points on the aphasia subitem.
- Severe attentional and executive function deficits that prevent the comprehension of simple instructions, determined by the Catherine Bergego Scale and/or Cancel Bells Test and/or Line Bisection Test.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Neglect Conventional intervenction
Conventional occupational therapy intervention for the treatment of neglect
|
Bottom - up, restorative occupational therapy approach to unilateral neglect
|
|
Experimental: Neglect Virtual Intervention
Use of an interactive screen for neglect rehabilitation
|
Use of the Myro Interactive Screen (Tyromotion) as a tool for occupational therapy approach in patients with unilateral neglect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Catherine Bergego Scale for Neglect
Time Frame: from the start of treatment until 4 weeks
|
The Catherine Bergego Scale (CBS) is a functional assessment composed of 10 items, each scored on a 0-3 scale, resulting in a total score ranging from 0 to 30.
A score of 0 indicates the absence of neglect, whereas a score of 30 reflects severe unilateral neglect.
Higher total scores represent worse performance and greater severity of neglect, while lower scores indicate better functional outcomes.
Severity levels are commonly categorized as follows: 1-10 points indicate mild behavioral neglect, 10-20 indicate moderate neglect, and 21-30 represent severe behavioral neglect.
|
from the start of treatment until 4 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Vanina Lado, Fundacion para la Lucha de las Enfermedades Neurologicas de la Infancia, Sede Escobar
Publications and helpful links
General Publications
- Williams, L. J., Kernot, J., Hillier, S. L., & Loetscher, T. (2021). Subtipos de negligencia espacial, definiciones y herramientas de evaluación: Una revisión de alcance. Frontiers in Neurology, 12, 742365.
- Williams, L., Loetscher, T., Hillier, S., Hreha, K., Jones, J., Bowen, A., & Kernot, J. (2024, mayo). Identifying spatial neglect - an updated systematic review of the psychometric properties of assessment tools in adults post-stroke. Neuropsychological Rehabilitation. https://doi.org/10.1080/09602011.2024.2346212
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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