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NCT Number: NCT02680171

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prism Goggles

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.

Non-Shifting Goggles

Other

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

Other names: Control condition

Primary outcomes

  1. Change in Sunnybrook Neglect Assessment Procedure (SNAP)

    Time frame: Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)

    Test of neglect severity

Secondary outcomes

  1. Change in Johnny Shirt Visual Scanning Task

    Time frame: 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)

    Test of neglect severity

  2. Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)

    Time frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)

    Test of neglect severity

  3. Change in Catherine Bergego Scale (CBS)

    Time frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)

    Scale of neglect impact on daily activities

  4. Change in Halifax Neglect Severity Scale

    Time frame: 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)

    Scale of neglect impact on daily activities

  5. Change in Functional Independence Measure (FIM)

    Time frame: Taken at baseline and at discharge up to 3 months

    Measure of functional independence

  6. Frenchay Activities Index

    Time frame: Taken at approximately 3 months post-discharge

    Measure of functional independence

  7. Length of inpatient stay at the Rehabilitation Centre

    Time frame: From admission to discharge up to 3 months

    Measure of hospital utilization

  8. Discharge destination from Rehabilitation Centre

    Time frame: At time of discharge up to 3 months from admission

    Measure of hospital utilization

  9. Change in Proprioceptive and Visuo-motor pointing midline tasks

    Time frame: Taken from immediately before and at end of treatment session, about 10 minutes

    Used to assess prism adaptation after-effects

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2016
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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