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| ID | Type | Description | Link |
|---|---|---|---|
| RX003474-01 | Other Grant/Funding Number | VAORD |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate | Experimental | Participants will enter treatment after one week baseline |
|
| Delayed | Experimental | Participants will enter treatment after two week baseline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prism Adaptation Treatment | Behavioral | Spatial retraining treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire | Assessment of satisfaction and perceived value of Prism Adaptation Treatment; scores range from 8-32, with higher scores indicating greater satisfaction | Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group) |
| 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. | Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group) |
| 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 | 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) |
| Functional Independence Measure | Assessment of cognitive and motor function; scores range from 18-126, with a higher score indicating greater functional independence | 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) |
| Behavioral Inattention Test- Conventional Subtest | Assessment of spatial neglect; scores range from 0-146, with lower scores indicating more severe spatial neglect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy D. Rodriguez, PhD | Atlanta VA Medical and Rehab Center, Decatur, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033-4004 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate | Participants will enter treatment after one week baseline Prism Adaptation Treatment: Spatial retraining treatment |
| FG001 | Delayed | Participants will enter treatment after two week baseline Prism Adaptation Treatment: Spatial retraining treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate | Participants will enter treatment after one week baseline Prism Adaptation Treatment: Spatial retraining treatment |
| BG001 | Delayed | Participants will enter treatment after two week baseline Prism Adaptation Treatment: Spatial retraining treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group) |
|
Adverse event data were collected from the time of study entry until the end of study participation, an average of 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate | Participants will enter treatment after one week baseline Prism Adaptation Treatment: Spatial retraining treatment |
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Significant issues were encountered with study recruitment. Screen fail rate was higher than anticipated. This resulted in a very small sample size. Data should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rodriguez | Atlanta VA Medical Center | 404-321-6111 | amy.rodriguez@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 | Jul 24, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2022 | Jul 29, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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Multiple baseline, delayed treatment design
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Neurologist will conduct blinded classification of "frontal" or "nonfrontal" lesions
| 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) |
| 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 | 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) |
| Wolf Motor Function Test | Assessment of motor function; scores range from 0-75, with higher scores indicating less impairment in motor function | 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) |
| Defense and Veterans Pain Rating Scale | Assessment of pain; scores range from 0-10, with higher scores indicating more severe pain | 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) |
| Classification of Lesion Location | Assessment of whether lesion is "frontal" or "nonfrontal" | Baseline |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Score on a 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) |
|
|
|
| Primary | Functional Independence Measure | Assessment of cognitive and motor function; scores range from 18-126, with a higher score indicating greater functional independence | Posted | Mean | Standard Deviation | Score on a 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) |
|
|
|
| Primary | Behavioral Inattention Test- Conventional Subtest | Assessment of spatial neglect; scores range from 0-146, with lower scores indicating more severe spatial neglect | Posted | Mean | Standard Deviation | Score on a 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) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Score on a 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) |
|
|
|
| Primary | Wolf Motor Function Test | Assessment of motor function; scores range from 0-75, with higher scores indicating less impairment in motor function | Posted | Mean | Standard Deviation | Score on a 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) |
|
|
|
| Primary | Defense and Veterans Pain Rating Scale | Assessment of pain; scores range from 0-10, with higher scores indicating more severe pain | Posted | Mean | Standard Deviation | Score on a 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) |
|
|
|
| Primary | Classification of Lesion Location | Assessment of whether lesion is "frontal" or "nonfrontal" | Unable to obtain records to complete this analysis | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Delayed | Participants will enter treatment after two week baseline Prism Adaptation Treatment: Spatial retraining treatment | 0 | 2 | 0 | 2 | 0 | 2 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Two Weeks Post-Treatment |
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| Two Weeks Post-Treatment |
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| Two Weeks Post-Treatment |
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| Two Weeks Post-Treatment |
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| Two Weeks Post-Treatment |
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| Two Weeks Post-Treatment |
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