Clinical trial NCT04387162: Prism Adaptation in Left Brain Stroke
Official title: One Treatment, Multiple Targets: Prism Adaptation and Left Brain Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Spatial Neglect
Stroke
Keywords: aphasia
spatial neglect
rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-05-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple baseline, delayed treatment design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* History of brain conditions other than left brain stroke, including clinical right brain pathology.

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
measure: Credibility/Expectancy Questionnaire
timeFrame: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
measure: Barthel Index
timeFrame: 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)
measure: Functional Independence Measure
timeFrame: 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)
measure: Behavioral Inattention Test- Conventional Subtest
timeFrame: 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)
measure: Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process
timeFrame: 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)
measure: Wolf Motor Function Test
timeFrame: 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)
measure: Defense and Veterans Pain Rating Scale
timeFrame: 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)
measure: Classification of Lesion Location
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Amy D. Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: