One Treatment, Multiple Targets: Prism Adaptation and Left Brain Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Client Satisfaction Questionnaire
研究概览
简要总结
Of the 15,000 Veterans who are hospitalized for stroke each year more than half experience spatial and motor impairments and pain. Spatial-motor-sensory problems limit functioning and independence, which is costly to Veterans, their families, and society. Currently, spatial-motor-sensory problems are targeted using different treatments. However, there is a treatment that has shown promise in simultaneously targeting spatial function, motor function and pain in right-brain stroke. The investigators propose to investigate the feasibility of using adapted spatial-motor sensory assessment and treatment procedures for Veterans with left-brain stroke who have language and cognitive impairment. The next step will be to conduct a large-scale study focused on this multi-target treatment for more efficient and effective stroke rehabilitation. The investigators expect this line of research to increase functioning, independence and quality of life in Veteran stroke survivors.
详细描述
The functional disability experienced by Veterans after stroke, and the limited rehabilitation resources available, highlight the importance of identifying feasible treatments acting on more than one recovery target. Currently, there are separate and modality-specific treatment pathways for cognitive and motor impairments. These modality-specific treatment pathways lead to fragmentation of care, and under-identification and under-treatment of invisible disabilities, such as spatial neglect, aphasia and pain. The result is longer hospital stays, greater risk of falls, and poor functional outcomes. Employing a treatment that simultaneously addresses multiple targets will ensure that the investigators provide the needed care for >50% of post-stroke Veterans who have both visible and invisible disabilities, during the critical post-acute period of recovery.
Prism adaptation treatment (PAT) is a 10-day regimen reported to be inexpensive, replicable and effective for treatment of spatial neglect, and studies have demonstrated that it also enhances everyday activities and motor recovery and reduces chronic post-stroke pain in patients with right brain stroke. Additionally, brain mapping methods have shown that in patients with right brain stroke, those with frontal lesions respond optimally to PAT. No studies have investigated PAT in left-brain stroke patients with language and cognitive impairment. To address this research gap, the investigators will address the following aims:
Aim 1: To demonstrate the feasibility of adapted PAT procedures in patients with aphasia and memory impairment. .
Aim 2: To demonstrate the feasibility of adapted methods for assessing spatial and motor function and pain in patients with aphasia and memory impairment.
Aim 3: To demonstrate the feasibility of using information about lesion location from the radiology report to classify frontal vs. nonfrontal lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Neurologist will conduct blinded classification of "frontal" or "nonfrontal" lesions
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-3 months post-stroke, entering outpatient treatment
- •proficient English speakers
- •experiencing moderate functional disability as measured by Functional Independence Measure (FIM), observational or telephone-administered FONE-FIM
- •experiencing aphasia as determined by a Western Aphasia Battery Aphasia Quotient and memory impairment as determined by the Brief Visuospatial Memory Test- Revised, the Hopkins Verbal Learning Test- Revised or digit span forward and backward
- •able to provide informed consent to participate, using aphasia-accessible process, as needed.
排除标准
- •History of brain conditions other than left brain stroke, including clinical right brain pathology.
结局指标
主要结局
Client Satisfaction Questionnaire
时间窗: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
Assessment of satisfaction and perceived value of Prism Adaptation Treatment; scores range from 8-32, with higher scores indicating greater satisfaction
Credibility/Expectancy Questionnaire
时间窗: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
Assessment of whether Prism Adaptation Treatment is believable, convincing and logical (credibility) and the expectations for treatment-induced improvement (expectancy); two rating scales with one scale ranging from 1-9 and from 0%-100%, with higher scores indicating greater credibility and expectancy.
Functional Independence Measure
时间窗: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)
Assessment of cognitive and motor function; scores range from 18-126, with a higher score indicating greater functional independence
Behavioral Inattention Test- Conventional Subtest
时间窗: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)
Assessment of spatial neglect; scores range from 0-146, with lower scores indicating more severe spatial neglect
Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process
时间窗: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)
Assessment of spatial neglect; scores range from 0-30, with higher scores indicating more severe spatial neglect
Barthel Index
时间窗: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)
Assessment of functional disability by activities of daily living; scores range from 0-100, with higher score indicating greater independence and less functional disability
Defense and Veterans Pain Rating Scale
时间窗: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)
Assessment of pain; scores range from 0-10, with higher scores indicating more severe pain
Classification of Lesion Location
时间窗: Baseline
Assessment of whether lesion is "frontal" or "nonfrontal"
Wolf Motor Function Test
时间窗: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)
Assessment of motor function; scores range from 0-75, with higher scores indicating less impairment in motor function
次要结局
未报告次要终点