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Prism Adaptation in Left Brain Stroke

Not Applicable
Completed
Conditions
Aphasia
Spatial Neglect
Stroke
Interventions
Behavioral: Prism Adaptation Treatment
Registration Number
NCT04387162
Lead Sponsor
VA Office of Research and Development
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ImmediatePrism Adaptation TreatmentParticipants will enter treatment after one week baseline
DelayedPrism Adaptation TreatmentParticipants will enter treatment after two week baseline
Primary Outcome Measures
NameTimeMethod
Client Satisfaction QuestionnaireImmediately 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 QuestionnaireImmediately 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 MeasureWeekly 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 SubtestWeekly 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 ProcessWeekly 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 IndexWeekly 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 ScaleWeekly 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 LocationBaseline

Assessment of whether lesion is "frontal" or "nonfrontal"

Wolf Motor Function TestWeekly 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

🇺🇸

Decatur, Georgia, United States

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