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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2021-08-30

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.

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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.

Conditions

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Sensory Neglect Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Prism Goggles

Intervention Type BEHAVIORAL

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 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.

Group Type SHAM_COMPARATOR

Non-Shifting Goggles

Intervention Type OTHER

Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.

Interventions

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Prism Goggles

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.

Intervention Type BEHAVIORAL

Non-Shifting Goggles

Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.

Intervention Type OTHER

Other Intervention Names

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Control condition

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.