Prism Adaptation in Left Brain Stroke

NCT04387162 | Completed Results

• 2 other identifiers: B3474-PRX003474-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Spatial Neglect; Stroke

Keywords

aphasia; spatial neglect; rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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

  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

Study Arms (2)

Immediate

EXPERIMENTAL

Participants will enter treatment after one week baseline

Behavioral: Prism Adaptation Treatment

Delayed

EXPERIMENTAL

Participants will enter treatment after two week baseline

Behavioral: Prism Adaptation Treatment

Interventions

Prism Adaptation Treatment BEHAVIORAL

Spatial retraining treatment

Delayed; Immediate

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of brain conditions other than left brain stroke, including clinical right brain pathology.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Amy Rodriguez
• Organization: Atlanta VA Medical Center

amy.rodriguez@va.gov

404-321-6111

Study Officials

• Amy D. Rodriguez, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neurologist will conduct blinded classification of "frontal" or "nonfrontal" lesions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Multiple baseline, delayed treatment design

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: February 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: April 9, 2025
• Results First Posted: August 27, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)