SCRiCaViPS Screening and Rehabilitation of Visual Field Defects in Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Recovery rate in patients who receive training with multisensory audio-visual stimuli
研究概览
简要总结
In this study, the investigators will use a wearable device capable of performing this bedside assessment to evaluate the incidence of visual field loss in post-stroke patients. Furthermore, for those with visual field loss, the investigators will investigate whether integrating multisensory audio-visual rehabilitation into the standard physical rehabilitation protocol can help improve visual field loss compared to standard rehabilitation alone.
详细描述
The objectives of the research are:
- To quantify the incidence and severity of visual field defects in subjects with a recent cerebrovascular accident admitted to the hospital Neurology Unit
- To evaluate the rate of spontaneous recovery of visual field defects during observation .
- To test the effectiveness of an early and intensive visual rehabilitation intervention based on multisensory stimulation in reducing the severity of the aforementioned visual defect.
The research is planned to be conducted in Genova Italy and to include 300 patients.
In this study, the investigators will recruit acute post-stroke patients from the Neurology Unit of IRCCS Policlinico San Martino hospital. The study will use a wearable device (PalmScan VF2000) to assess the visual field defects. Those with significant visual field defects will be randomly assigned to either the visual rehabilitation group, receiving visual rehabilitation treatment integrated into their physical rehabilitation protocol, or the standard group. Inclusion criteria include: age between 18 and 90 years, post-stroke patients (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to the Neurology Unit of the IRCCS Policlinico San Martino hospital, able to understand and sign the informed consent for study participation, and having mobility in at least one upper limb. Exclusion criteria include: cognitive impairment that limits understanding of the informed consent or testing, difficulty with both upper limb movements, presence of ocular comorbidity that could affect pre-ictal visual field assessment, presence of fluid aphasia, neglect or deviation of the head and gaze, impaired consciousness or delirium. Baseline assessments will be conducted at the Neurology Unit of the IRCCS Policlinico San Martino hospital.
After the baseline assessment, all participants diagnosed with visual field impairment will be assigned to the David Chiossone Foundation, with the option of being referred to a post-acute residential facility or undergoing outpatient treatment. Otherwise, patients requiring intensive care will be referred to another competent local center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 99 years with stroke (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to Neurology in IRCCS San Martino Polyclinic Hospital with the ability to understand and sign the informed consent for study participation.
- •Mobility of at least one upper limb.
排除标准
- •Presence of cognitive impairment (with an MMSE score less than 24), which limits the understanding of the informed consent or the ability to perform the test.
- •Difficulty moving both upper limbs.
- •Presence of ocular comorbidity that could affect visual field assessment before stroke.
- •Presence of fluent aphasia, neglect, or head and gaze deviation.
- •Presence of disturbances in the state of consciousness
- •Presence of delirium
研究组 & 干预措施
Standard intervention
This group of patients will continue according to current clinical practice (control group), directed towards possible neuro-motor rehabilitation until full recovery, and will have access to visual rehabilitation following full recovery of physical condition.
The follow up visual field test will detect the percentage of spontaneous recovery of the visual field defect during the observation period
干预措施: Early visual field test (Diagnostic Test)
Early intervention rehabilitation
The experimental group will be enrolled for a early rehabilitation intervention through multisensory stimulations, a rehabilitation specifically aimed at improving the visual field deficit, possibly combined with standard physical rehabilitation in temporary hospitalization facilities or protected hospital discharge.
干预措施: Early multisensory audio-visual stimulation training (Other)
Early intervention rehabilitation
The experimental group will be enrolled for a early rehabilitation intervention through multisensory stimulations, a rehabilitation specifically aimed at improving the visual field deficit, possibly combined with standard physical rehabilitation in temporary hospitalization facilities or protected hospital discharge.
干预措施: Early visual field test (Diagnostic Test)
结局指标
主要结局
Recovery rate in patients who receive training with multisensory audio-visual stimuli
时间窗: 2 months
Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points
Spontaneous recovery rate of visual field defects after stroke
时间窗: 2 months
Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points
次要结局
- Incidence of visual field defects in post-stroke patients(1 year)