Prism Adaptation in Left Brain Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Aphasia; Spatial Neglect
• Intervention / Treatment: Behavioral: Prism Adaptation Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033-4004
      • Atlanta VA Medical and Rehab Center, Decatur, GA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate; Participants will enter treatment after one week baseline	Behavioral: Prism Adaptation Treatment; Spatial retraining treatment
Experimental: Delayed; Participants will enter treatment after two week baseline	Behavioral: Prism Adaptation Treatment; Spatial retraining treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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); 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)
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)
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)
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)
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)
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)
Classification of lesion location	Assessment of whether lesion is "frontal" or "nonfrontal"	Baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Amy D. Rodriguez, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; aphasia; spatial neglect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: B3474-P; RX003474-01 (Other Grant/Funding Number: VAORD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No