Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Stroke

June 20, 2023 updated by: Gail Eskes, Nova Scotia Health Authority

Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Right Hemisphere Stroke

Spatial neglect is a common attention disorder after right hemisphere stroke and is associated with decreased independence and quality of life. Despite its high prevalence in the stroke population, there is currently no standard of care for the treatment of neglect. Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into clinical care has been limited likely due to the lack of standardized procedures. The investigators have developed a computerized PA technique designed to better engage patients and assist clinicians. In this study the investigators aim to evaluate the feasibility and effectiveness of the computerized PA procedure in a typical health care setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.

Study Overview

Status

Completed

Conditions

Detailed Description

There is an unmet need for effective and feasible interventions for spatial neglect after right hemisphere stroke. Neglect is a frequent problem after stroke and makes it difficult for individuals to pay attention and notice information coming from the left side of their world. Thus, they often miss food on the left side of their plate, fail to wash or groom the left side of their face or body, or run into objects on the left side of the hall when walking or using their wheelchair. Neglect is associated with slower recovery, reduced independence, longer stays in rehabilitation and need for more resources when discharged. The investigators have developed a novel and simple computerized prism adaptation (PA) procedure for treating neglect, but the investigators don't know yet whether it is feasible and effective in a typical health care setting. Thus, the purpose of this project is to conduct a randomized, controlled clinical trial, comparing the PA method to a control intervention for the treatment of neglect. The investigators will measure feasibility of use in a clinical setting and effectiveness in terms of impairment (i.e., does PA improve neglect symptoms?), activities (i.e., does having PA improve independence in daily activities) and health care outcomes (i.e., does giving PA shorten length of stay and decrease the need for resources on discharge?). By treating neglect with PA, the overall aim is to improve the health care outcomes for those with neglect and to reduce need for extended hospital care.

A controlled, randomized design will be used in the present study. Patients will be randomly assigned (with stratification related to neglect severity) to PA (experimental) or sham (control) conditions and complete 10, 30-minute intervention sessions over approximately two weeks. These intervention sessions will involve a novel and simple computerized prism adaptation, Peg-The-Mole (PTM). Outcome measures will be collected before and after each treatment, as well as at baseline, and a three month follow-up over the phone.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3N5
        • Nova Scotia Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Experience mild to severe symptoms of neglect (as measured by the Sunnybrook Neglect Assessment Procedure and/or as determined based on clinical judgment of the treating team)
  • Be willing to participate
  • Be able to consent to participate
  • Be medically stable
  • Have normal or corrected to normal vision
  • Be able to point to targets presented on a computer screen.

Exclusion Criteria:

  • Other neurological disease (e.g., Multiple Sclerosis, Parkinsons disease)
  • Dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prism adaptation treatment
Prism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.
Patients in the experimental condition will wear prism goggles while completing a computerized aiming task. This prisms will shift the patients' vision 10 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out over several days.
Sham Comparator: Sham prism adaptation treatment
Non-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field.
Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.
Other Names:
  • Control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sunnybrook Neglect Assessment Procedure (SNAP)
Time Frame: Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)
Test of neglect severity
Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Johnny Shirt Visual Scanning Task
Time Frame: Taken at baseline, after five intervention sessions are completed (approximately 1 week post-treatment start), and after the intervention (approximately two weeks post-treatment start)
Test of neglect severity
Taken at baseline, after five intervention sessions are completed (approximately 1 week post-treatment start), and after the intervention (approximately two weeks post-treatment start)
Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)
Time Frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Test of neglect severity
Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Change in Catherine Bergego Scale (CBS)
Time Frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Scale of neglect impact on daily activities
Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Change in Halifax Neglect Severity Scale
Time Frame: Taken after the intervention (approximately two weeks post-treatment start) and at follow-up (approximately 3 months post-discharge from the Nova Scotia Rehabilitation and Arthritis Centre)
Scale of neglect impact on daily activities
Taken after the intervention (approximately two weeks post-treatment start) and at follow-up (approximately 3 months post-discharge from the Nova Scotia Rehabilitation and Arthritis Centre)
Change in Functional Independence Measure (FIM)
Time Frame: Taken at baseline and at discharge up to 3 months
Measure of functional independence
Taken at baseline and at discharge up to 3 months
Frenchay Activities Index
Time Frame: Taken at approximately 3 months post-discharge
Measure of functional independence
Taken at approximately 3 months post-discharge
Length of inpatient stay at the Rehabilitation Centre
Time Frame: From admission to discharge up to 3 months
Measure of hospital utilization
From admission to discharge up to 3 months
Discharge destination from Rehabilitation Centre
Time Frame: At time of discharge up to 3 months from admission
Measure of hospital utilization
At time of discharge up to 3 months from admission
Change in Proprioceptive and Visuo-motor pointing midline tasks
Time Frame: Taken from immediately before and at end of treatment session, about 10 minutes
Used to assess prism adaptation after-effects
Taken from immediately before and at end of treatment session, about 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gail A Eskes, PhD, Nova Scotia Health Authority; Dalhousie University
  • Principal Investigator: Richard Braha, PhD, Nova Scotia Health Authority
  • Study Chair: Anne Sophie Champod, PhD, Dalhousie University; Acadia University
  • Study Chair: Joy Boyce, BScOT, Nova Scotia Health Authority
  • Study Chair: Myrna King, BScOT, Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2018

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimated)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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