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Prism Adaptation in Left Brain Stroke

Primary Purpose

Aphasia, Spatial Neglect, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prism Adaptation Treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring aphasia, spatial neglect, rehabilitation

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate

Delayed

Arm Description

Participants will enter treatment after one week baseline

Participants will enter treatment after two week baseline

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire
Assessment of satisfaction and perceived value of Prism Adaptation Treatment; scores range from 8-32, with higher scores indicating greater satisfaction
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.
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
Functional Independence Measure
Assessment of cognitive and motor function; scores range from 18-126, with a higher score indicating greater functional independence
Behavioral Inattention Test- Conventional Subtest
Assessment of spatial neglect; severity scores range from 1-6, with higher scores indicating more severe spatial neglect
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
Wolf Motor Function Test
Assessment of motor function; scores range from 0-75, with higher scores indicating less impairment in motor function
Defense and Veterans Pain Rating Scale
Assessment of pain; scores range from 0-10, with higher scores indicating more severe pain
Classification of lesion location
Assessment of whether lesion is "frontal" or "nonfrontal"

Secondary Outcome Measures

Full Information

First Posted
May 8, 2020
Last Updated
February 7, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04387162
Brief Title
Prism Adaptation in Left Brain Stroke
Official Title
One Treatment, Multiple Targets: Prism Adaptation and Left Brain Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Spatial Neglect, Stroke
Keywords
aphasia, spatial neglect, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multiple baseline, delayed treatment design
Masking
Outcomes Assessor
Masking Description
Neurologist will conduct blinded classification of "frontal" or "nonfrontal" lesions
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Experimental
Arm Description
Participants will enter treatment after one week baseline
Arm Title
Delayed
Arm Type
Experimental
Arm Description
Participants will enter treatment after two week baseline
Intervention Type
Behavioral
Intervention Name(s)
Prism Adaptation Treatment
Intervention Description
Spatial retraining treatment
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire
Description
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)
Title
Credibility/Expectancy Questionnaire
Description
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)
Title
Barthel Index
Description
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); 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)
Title
Functional Independence Measure
Description
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); 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)
Title
Behavioral Inattention Test- Conventional Subtest
Description
Assessment of spatial neglect; severity scores range from 1-6, with higher scores indicating more severe spatial neglect
Time Frame
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)
Title
Catherine Bergego Scale via the Kessler Foundation Neglect Assessment Process
Description
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); 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)
Title
Wolf Motor Function Test
Description
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); 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)
Title
Defense and Veterans Pain Rating Scale
Description
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); 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)
Title
Classification of lesion location
Description
Assessment of whether lesion is "frontal" or "nonfrontal"
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy D Rodriguez, PhD
Phone
(404) 321-6111
Ext
204201
Email
amy.rodriguez@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Britan Lang, MPH
Phone
(404) 321-6111
Ext
7027
Email
Laura.Britan_Lang@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy D. Rodriguez, PhD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley N Scales
Phone
404-321-6111
Ext
23952
Email
Ashley.Scales@va.gov
First Name & Middle Initial & Last Name & Degree
Laura Britan Lang, MPH
Phone
(404) 321-6111
Ext
7027
Email
Laura.Britan_Lang@va.gov
First Name & Middle Initial & Last Name & Degree
Amy D. Rodriguez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Prism Adaptation in Left Brain Stroke

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