Prism Adaptation in Left Brain Stroke

Stroke Clinical Trial

Official title:

One Treatment, Multiple Targets: Prism Adaptation and Left Brain Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387162
• Other study ID #: B3474-P
• Secondary ID: RX003474-01
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Spatial Neglect
• Stroke

Intervention

Behavioral:
• Prism Adaptation Treatment
Spatial retraining treatment

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
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.	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	Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from 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	Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7)
Primary	Behavioral Inattention Test- Conventional Subtest	Assessment of spatial neglect; severity scores range from 1-6, with higher scores indicating more severe spatial neglect	Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from 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	Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from 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	Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from 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	Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7)
Primary	Classification of lesion location	Assessment of whether lesion is "frontal" or "nonfrontal"	Baseline