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临床试验/NCT07475611
NCT07475611Enrolling By Invitation不适用

Effectiveness of an Interactive Screen in the Rehabilitation of Neglect in Adults With Subacute Stroke: A Randomized Controlled Trial in Argentina.

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
12
试验地点
1
主要终点
Catherine Bergego Scale for Neglect

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Neglect Conventional intervenction

Other

Conventional occupational therapy intervention for the treatment of neglect

干预措施: occupational therapy conventional treatment (Other)

Neglect Virtual Intervention

Experimental

Use of an interactive screen for neglect rehabilitation

干预措施: Myro Interactive Screen (Tyromotion) as a tool for occupational therapy approach in patients with unilateral neglect (Device)

结局指标

主要结局

Catherine Bergego Scale for Neglect

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanina Lado

Occupational Therapy Coordinator

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

研究点 (1)

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