Aphasia, Spatial Neglect, Stroke
Conditions
Keywords
aphasia, spatial neglect, rehabilitation
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.
Interventions
BEHAVIORALPrism Adaptation Treatment
Spatial retraining treatment
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Neurologist will conduct blinded classification of frontal or nonfrontal lesions
Intervention model description
Multiple baseline, delayed treatment design
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire | 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 | 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. |
| Barthel Index | 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 |
| Functional Independence Measure | 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 | 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 | 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 |
| Wolf Motor Function Test | 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 |
| Defense and Veterans Pain Rating Scale | 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 | Baseline | Assessment of whether lesion is frontal or nonfrontal |
Countries
United States
Participant flow
Pre-assignment details
Eight participants were consented into the study to complete screening procedures and ultimately did not meet eligibility criteria. These eight participants were not assigned to a study group.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment | 3 |
| Delayed Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Immediate | Total | Delayed |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 9.1 | 62.4 years STANDARD_DEVIATION 10.5 | 53.5 years STANDARD_DEVIATION 3.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
Barthel Index
Assessment of functional disability by activities of daily living; scores range from 0-100, with higher score indicating greater independence and less functional disability
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate | Barthel Index | Two Weeks Post-Treatment | 71.7 Score on a scale | Standard Deviation 24.7 |
| Immediate | Barthel Index | Baseline | 70.8 Score on a scale | Standard Deviation 23.5 |
| Immediate | Barthel Index | Immediate Post-Treatment | 75.0 Score on a scale | Standard Deviation 22.9 |
| Delayed | Barthel Index | Two Weeks Post-Treatment | 85.0 Score on a scale | Standard Deviation 7.1 |
| Delayed | Barthel Index | Baseline | 86.9 Score on a scale | Standard Deviation 10.9 |
| Delayed | Barthel Index | Immediate Post-Treatment | 82.5 Score on a scale | Standard Deviation 10.6 |
Primary
Behavioral Inattention Test- Conventional Subtest
Assessment of spatial neglect; scores range from 0-146, with lower scores indicating more severe spatial neglect
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate | Behavioral Inattention Test- Conventional Subtest | Baseline | 115.3 Score on a scale | Standard Deviation 45.7 |
| Immediate | Behavioral Inattention Test- Conventional Subtest | Immediate Post-Treatment | 127.6 Score on a scale | Standard Deviation 24.9 |
| Immediate | Behavioral Inattention Test- Conventional Subtest | Two Weeks Post-Treatment | 127.3 Score on a scale | Standard Deviation 26.3 |
| Delayed | Behavioral Inattention Test- Conventional Subtest | Baseline | 120.4 Score on a scale | Standard Deviation 5.3 |
| Delayed | Behavioral Inattention Test- Conventional Subtest | Immediate Post-Treatment | 119.0 Score on a scale | Standard Deviation 19.8 |
| Delayed | Behavioral Inattention Test- Conventional Subtest | Two Weeks Post-Treatment | 123.5 Score on a scale | Standard Deviation 3.5 |
Primary
Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process
Assessment of spatial neglect; scores range from 0-30, with higher scores indicating more severe spatial neglect
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate | Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process | Baseline | 3.6 Score on a scale | Standard Deviation 2.6 |
| Immediate | Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process | Immediate Post-Treatment | 1.5 Score on a scale | Standard Deviation 2.6 |
| Immediate | Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process | Two Weeks Post-Treatment | 1.5 Score on a scale | Standard Deviation 2.6 |
| Delayed | Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process | Baseline | 3.2 Score on a scale | Standard Deviation 2.4 |
| Delayed | Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process | Immediate Post-Treatment | 1.5 Score on a scale | Standard Deviation 2.1 |
| Delayed | Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process | Two Weeks Post-Treatment | 2.5 Score on a scale | Standard Deviation 3.5 |
Primary
Classification of Lesion Location
Assessment of whether lesion is frontal or nonfrontal
Time frame: Baseline
Population: Unable to obtain records to complete this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate | Classification of Lesion Location | 0 Participants |
| Delayed | Classification of Lesion Location | 0 Participants |
Primary
Client Satisfaction Questionnaire
Assessment of satisfaction and perceived value of Prism Adaptation Treatment; scores range from 8-32, with higher scores indicating greater satisfaction
Time frame: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate | Client Satisfaction Questionnaire | 32 score on a scale | Standard Deviation 0 |
| Delayed | Client Satisfaction Questionnaire | 27 score on a scale | Standard Deviation 4.2 |
Primary
Credibility/Expectancy Questionnaire
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.
Time frame: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate | Credibility/Expectancy Questionnaire | Credibility | 6.2 score on a scale | Standard Deviation 1.6 |
| Immediate | Credibility/Expectancy Questionnaire | Expectancy | 56.7 score on a scale | Standard Deviation 30.6 |
| Delayed | Credibility/Expectancy Questionnaire | Credibility | 8.0 score on a scale | Standard Deviation 0.89 |
| Delayed | Credibility/Expectancy Questionnaire | Expectancy | 75.0 score on a scale | Standard Deviation 7.1 |
Primary
Defense and Veterans Pain Rating Scale
Assessment of pain; scores range from 0-10, with higher scores indicating more severe pain
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate | Defense and Veterans Pain Rating Scale | Baseline | 0.5 Score on a scale | Standard Deviation 0.84 |
| Immediate | Defense and Veterans Pain Rating Scale | Immediate Post-Treatment | 0.0 Score on a scale | Standard Deviation 0 |
| Immediate | Defense and Veterans Pain Rating Scale | Two Weeks Post-Treatment | 0.7 Score on a scale | Standard Deviation 1.2 |
| Delayed | Defense and Veterans Pain Rating Scale | Baseline | 3.7 Score on a scale | Standard Deviation 2.2 |
| Delayed | Defense and Veterans Pain Rating Scale | Immediate Post-Treatment | 3.5 Score on a scale | Standard Deviation 2.8 |
| Delayed | Defense and Veterans Pain Rating Scale | Two Weeks Post-Treatment | 1.5 Score on a scale | Standard Deviation 2.1 |
Primary
Functional Independence Measure
Assessment of cognitive and motor function; scores range from 18-126, with a higher score indicating greater functional independence
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate | Functional Independence Measure | Baseline | 88.2 Score on a scale | Standard Deviation 18.9 |
| Immediate | Functional Independence Measure | Immediate Post-Treatment | 94.7 Score on a scale | Standard Deviation 21.7 |
| Immediate | Functional Independence Measure | Two Weeks Post-Treatment | 95.0 Score on a scale | Standard Deviation 20.9 |
| Delayed | Functional Independence Measure | Baseline | 97.7 Score on a scale | Standard Deviation 9.1 |
| Delayed | Functional Independence Measure | Immediate Post-Treatment | 98.5 Score on a scale | Standard Deviation 13.4 |
| Delayed | Functional Independence Measure | Two Weeks Post-Treatment | 99.5 Score on a scale | Standard Deviation 13.4 |
Primary
Wolf Motor Function Test
Assessment of motor function; scores range from 0-75, with higher scores indicating less impairment in motor function
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate | Wolf Motor Function Test | Baseline | 35.5 Score on a scale | Standard Deviation 30.7 |
| Immediate | Wolf Motor Function Test | Immediate Post-Treatment | 35.7 Score on a scale | Standard Deviation 34.2 |
| Immediate | Wolf Motor Function Test | Two Weeks Post-Treatment | 35.0 Score on a scale | Standard Deviation 34.7 |
| Delayed | Wolf Motor Function Test | Baseline | 54.3 Score on a scale | Standard Deviation 22.8 |
| Delayed | Wolf Motor Function Test | Immediate Post-Treatment | 63.0 Score on a scale | Standard Deviation 14.1 |
| Delayed | Wolf Motor Function Test | Two Weeks Post-Treatment | 65.0 Score on a scale | Standard Deviation 12.7 |