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

Primary Purpose

Sensory Neglect, Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prism Goggles
Non-Shifting Goggles
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensory Neglect focused on measuring Cognitive Rehabilitation, Prism Adaptation, Stroke, Spatial Neglect

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nova Scotia Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Prism adaptation treatment

Sham prism adaptation treatment

Arm 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 (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field.

Outcomes

Primary Outcome Measures

Change in Sunnybrook Neglect Assessment Procedure (SNAP)
Test of neglect severity

Secondary Outcome Measures

Change in Johnny Shirt Visual Scanning Task
Test of neglect severity
Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)
Test of neglect severity
Change in Catherine Bergego Scale (CBS)
Scale of neglect impact on daily activities
Change in Halifax Neglect Severity Scale
Scale of neglect impact on daily activities
Change in Functional Independence Measure (FIM)
Measure of functional independence
Frenchay Activities Index
Measure of functional independence
Length of inpatient stay at the Rehabilitation Centre
Measure of hospital utilization
Discharge destination from Rehabilitation Centre
Measure of hospital utilization
Change in Proprioceptive and Visuo-motor pointing midline tasks
Used to assess prism adaptation after-effects

Full Information

First Posted
January 27, 2016
Last Updated
June 20, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02680171
Brief Title
Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Stroke
Official Title
Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Right Hemisphere Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensory Neglect, Stroke
Keywords
Cognitive Rehabilitation, Prism Adaptation, Stroke, Spatial Neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prism adaptation treatment
Arm Type
Experimental
Arm Description
Prism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.
Arm Title
Sham prism adaptation treatment
Arm Type
Sham Comparator
Arm Description
Non-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field.
Intervention Type
Behavioral
Intervention Name(s)
Prism Goggles
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-Shifting Goggles
Other Intervention Name(s)
Control condition
Intervention Description
Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.
Primary Outcome Measure Information:
Title
Change in Sunnybrook Neglect Assessment Procedure (SNAP)
Description
Test of neglect severity
Time Frame
Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)
Secondary Outcome Measure Information:
Title
Change in Johnny Shirt Visual Scanning Task
Description
Test of neglect severity
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)
Title
Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)
Description
Test of neglect severity
Time Frame
Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Title
Change in Catherine Bergego Scale (CBS)
Description
Scale of neglect impact on daily activities
Time Frame
Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Title
Change in Halifax Neglect Severity Scale
Description
Scale of neglect impact on daily activities
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)
Title
Change in Functional Independence Measure (FIM)
Description
Measure of functional independence
Time Frame
Taken at baseline and at discharge up to 3 months
Title
Frenchay Activities Index
Description
Measure of functional independence
Time Frame
Taken at approximately 3 months post-discharge
Title
Length of inpatient stay at the Rehabilitation Centre
Description
Measure of hospital utilization
Time Frame
From admission to discharge up to 3 months
Title
Discharge destination from Rehabilitation Centre
Description
Measure of hospital utilization
Time Frame
At time of discharge up to 3 months from admission
Title
Change in Proprioceptive and Visuo-motor pointing midline tasks
Description
Used to assess prism adaptation after-effects
Time Frame
Taken from immediately before and at end of treatment session, about 10 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail A Eskes, PhD
Organizational Affiliation
Nova Scotia Health Authority; Dalhousie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Braha, PhD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Sophie Champod, PhD
Organizational Affiliation
Dalhousie University; Acadia University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joy Boyce, BScOT
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Myrna King, BScOT
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Study Chair
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3N5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24952321
Citation
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.
Results Reference
background
PubMed Identifier
34196963
Citation
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.
Results Reference
derived

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

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