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

Not Applicable
Completed
Conditions
Sensory Neglect
Stroke
Interventions
Behavioral: Prism Goggles
Other: Non-Shifting Goggles
Registration Number
NCT02680171
Lead Sponsor
Nova Scotia Health Authority
Brief Summary

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Prism adaptation treatmentPrism GogglesPrism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.
Sham prism adaptation treatmentNon-Shifting GogglesNon-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field.
Primary Outcome Measures
NameTimeMethod
Change in Sunnybrook Neglect Assessment Procedure (SNAP)Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)

Test of neglect severity

Secondary Outcome Measures
NameTimeMethod
Frenchay Activities IndexTaken at approximately 3 months post-discharge

Measure of functional independence

Discharge destination from Rehabilitation CentreAt time of discharge up to 3 months from admission

Measure of hospital utilization

Change in Proprioceptive and Visuo-motor pointing midline tasksTaken from immediately before and at end of treatment session, about 10 minutes

Used to assess prism adaptation after-effects

Change in Functional Independence Measure (FIM)Taken at baseline and at discharge up to 3 months

Measure of functional independence

Change in Johnny Shirt Visual Scanning TaskTaken 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

Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)Taken at baseline and after the intervention (approximately two weeks post-treatment start)

Test of neglect severity

Change in Catherine Bergego Scale (CBS)Taken at baseline and after the intervention (approximately two weeks post-treatment start)

Scale of neglect impact on daily activities

Change in Halifax Neglect Severity ScaleTaken 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

Length of inpatient stay at the Rehabilitation CentreFrom admission to discharge up to 3 months

Measure of hospital utilization

Trial Locations

Locations (1)

Nova Scotia Health Authority

🇨🇦

Halifax, Nova Scotia, Canada

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