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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02680171
Enrollment
10
Registered
2016-02-11
Start date
2018-02-06
Completion date
2021-08-30
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory Neglect, Stroke

Keywords

Cognitive Rehabilitation, Prism Adaptation, Stroke, Spatial Neglect

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.

Interventions

BEHAVIORALPrism 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.

OTHERNon-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.

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Discharge destination from Rehabilitation CentreAt time of discharge up to 3 months from admissionMeasure of hospital utilization
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
Length of inpatient stay at the Rehabilitation CentreFrom admission to discharge up to 3 monthsMeasure of hospital utilization
Change in Functional Independence Measure (FIM)Taken at baseline and at discharge up to 3 monthsMeasure of functional independence
Frenchay Activities IndexTaken at approximately 3 months post-dischargeMeasure of functional independence
Change in Proprioceptive and Visuo-motor pointing midline tasksTaken from immediately before and at end of treatment session, about 10 minutesUsed to assess prism adaptation after-effects
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026