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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke, Sensory Neglect

Intervention / Treatment
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* Behavioral: Prism Goggles
* Other: Non-Shifting Goggles


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prism adaptation treatment<br>Prism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care. | Behavioral: Prism Goggles<br>* 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.<br>|
| Sham Comparator: Sham prism adaptation treatment<br>Non-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field. | Other: Non-Shifting Goggles<br>* Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.<br>* Other names: Control condition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sunnybrook Neglect Assessment Procedure (SNAP) | 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 | 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) | Test of neglect severity | Taken at baseline and after the intervention (approximately two weeks post-treatment start) | 
| Change in Catherine Bergego Scale (CBS) | 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 | 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) | Measure of functional independence | Taken at baseline and at discharge up to 3 months | 
| Frenchay Activities Index | Measure of functional independence | Taken at approximately 3 months post-discharge | 
| Length of inpatient stay at the Rehabilitation Centre | Measure of hospital utilization | From admission to discharge up to 3 months | 
| Discharge destination from Rehabilitation Centre | Measure of hospital utilization | At time of discharge up to 3 months from admission | 
| Change in Proprioceptive and Visuo-motor pointing midline tasks | Used to assess prism adaptation after-effects | Taken from immediately before and at end of treatment session, about 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Rehabilitation, Prism Adaptation, Stroke, Spatial Neglect