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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

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

Interventions

  • Prism goggles Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Prism adaptation treatment
    Description: Prism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.
  • Non-Shifting Goggles Other
    Other Names: Control condition
    Intervention Desc: Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.
    ARM 1: Kind: Experimental
    Label: Sham prism adaptation treatment
    Description: Non-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Sunnybrook Neglect Assessment Procedure (SNAP) Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start) No
Secondary Change in Johnny Shirt Visual Scanning Task 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) No
Secondary Change in Behavioural Inattention Test - Behaviour subtests (BIT-B) Taken at baseline and after the intervention (approximately two weeks post-treatment start) No
Secondary Change in Catherine Bergego Scale (CBS) Taken at baseline and after the intervention (approximately two weeks post-treatment start) No
Secondary Change in Halifax Neglect Severity Scale 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) No
Secondary Change in Functional Independence Measure (FIM) Taken at baseline and at discharge up to 3 months No
Secondary Frenchay Activities Index Taken at approximately 3 months post-discharge No
Secondary Length of inpatient stay at the Rehabilitation Centre From admission to discharge up to 3 months No
Secondary Discharge destination from Rehabilitation Centre At time of discharge up to 3 months from admission No
Secondary Change in Proprioceptive and Visuo-motor pointing midline tasks Taken from immediately before and at end of treatment session, about 10 minutes No

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