- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680171
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H3N5
- Nova Scotia Health Authority
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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Sham Comparator: 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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Test of neglect severity
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Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Test of neglect severity
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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)
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Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)
Time Frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
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Test of neglect severity
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Taken at baseline and after the intervention (approximately two weeks post-treatment start)
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Change in Catherine Bergego Scale (CBS)
Time Frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
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Scale of neglect impact on daily activities
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Taken at baseline and after the intervention (approximately two weeks post-treatment start)
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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)
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Scale of neglect impact on daily activities
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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)
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Change in Functional Independence Measure (FIM)
Time Frame: Taken at baseline and at discharge up to 3 months
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Measure of functional independence
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Taken at baseline and at discharge up to 3 months
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Frenchay Activities Index
Time Frame: Taken at approximately 3 months post-discharge
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Measure of functional independence
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Taken at approximately 3 months post-discharge
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Length of inpatient stay at the Rehabilitation Centre
Time Frame: From admission to discharge up to 3 months
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Measure of hospital utilization
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From admission to discharge up to 3 months
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Discharge destination from Rehabilitation Centre
Time Frame: At time of discharge up to 3 months from admission
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Measure of hospital utilization
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At time of discharge up to 3 months from admission
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Change in Proprioceptive and Visuo-motor pointing midline tasks
Time Frame: Taken from immediately before and at end of treatment session, about 10 minutes
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Used to assess prism adaptation after-effects
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Taken from immediately before and at end of treatment session, about 10 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gail A Eskes, PhD, Nova Scotia Health Authority; Dalhousie University
- Principal Investigator: Richard Braha, PhD, Nova Scotia Health Authority
- Study Chair: Anne Sophie Champod, PhD, Dalhousie University; Acadia University
- Study Chair: Joy Boyce, BScOT, Nova Scotia Health Authority
- Study Chair: Myrna King, BScOT, Nova Scotia Health Authority
Publications and helpful links
General Publications
- Champod AS, Taylor K, Eskes GA. Development of a new computerized prism adaptation procedure for visuo-spatial neglect. J Neurosci Methods. 2014 Sep 30;235:65-75. doi: 10.1016/j.jneumeth.2014.05.023. Epub 2014 Jun 19.
- Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRICSpatialNeglect2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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