Engaging Mobile Prism Adaptation Treatment at Home (EMPATH)
Primary Purpose
Spatial Neglect
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Prism Adaptation - 15-degree prism goggles
Prism Adaptation - 5-degree prism goggles
Sponsored by
About this trial
This is an interventional treatment trial for Spatial Neglect focused on measuring Spatial Neglect, Prism Adaptation, Rehabilitation, Stroke
Eligibility Criteria
Inclusion Criteria:
- Have experienced a right hemisphere stroke (confirmed by a clinician)
- Experience mild to severe symptoms of neglect
- Be willing and able to consent to participate
- Be medically stable
- Have self-reported normal to corrected-to-normal vision
- Be able to point to targets presented on a computer screen
- Live within a two-hour radius of Halifax
Exclusion Criteria:
Other existing neurological disorders (e.g., dementia, multiple sclerosis, epilepsy).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prism adaptation treatment
Placebo control prism adaptation treatment
Arm Description
Prism Goggles with 15-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.
Prism goggles with 5-degree rightward deviating prism lenses will be used to maintain the double-blind methodology.
Outcomes
Primary Outcome Measures
Test of neglect severity 1
Change in Behavioural Inattention Test - All conventional subtests (BIT-C)
Test of neglect severity 2
Change in after-effects measured by a modified proprioceptive-and-visual straight-ahead outcome task without the use of an occlusion board
Test of neglect severity 3
Change in Behavioural Inattention Test - Select behavioural subtests (BIT-B): Article Reading, Menu Reading, and Picture Scanning
Test of neglect impact on daily activities
Change in an Eschenbeck Standardized Activities of Daily Living task: Filling out a Form
Scale of neglect impact on daily activities
Change in Halifax Neglect Impact Scale
Measure of feasibility Measure of feasibility
Treatment compliance with the intervention schedule daily
Measure of feasibility 2
Patient feedback exit questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT05595668
First Posted
October 14, 2022
Last Updated
October 26, 2022
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT05595668
Brief Title
Engaging Mobile Prism Adaptation Treatment at Home
Acronym
EMPATH
Official Title
Feasibility and Effectiveness of a New Computerized Treatment Protocol for Spatial Neglect Post Stroke During Inpatient and Outpatient Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
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 disorder after stroke which leads to problems with noticing or responding to information from the left side of the body or space. This condition has been linked to reduced independence in a wide range of daily life activities including eating, dressing, and mobility. Despite its high prevalence in stroke patients, there is currently no standard of care for spatial neglect. Prism adaptation (PA) is a promising treatment, however, there are limitations to using PA in standard clinical care as it requires daily exposure for at least two weeks, yet access to equipment and supervision is limited. To solve this problem, the investigators have developed a new game-like PA treatment (Peg-the-Mole, PTM) that can be used at home without the need for daily in person therapist set-up and supervision. In this study the investigators aim to evaluate the feasibility and effectiveness of the gamified and portable PA procedure in an inpatient and home setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.
Detailed Description
Spatial neglect is a common debilitating cognitive syndrome after stroke which is characterized by an inability to pay attention or respond to the left side of space. Thus, individuals who face this condition often experience difficulties with mobility, reading, and self-care activities such as eating, dressing, and grooming Individuals who face this condition often experience difficulties with mobility, reading, and self-care activities such as eating, dressing, and grooming which lead to increased assistance needed from a caretaker. Although this syndrome has been linked to poor rehabilitation outcomes and reduced independence in everyday life, there is currently an unmet need for an effective and feasible intervention for the treatment of spatial neglect. The investigators have developed and validated a novel, simple, and gamified computerized prism adaptation (PA) procedure for the treatment of spatial neglect. The goal of the present study is to extend this treatment to iPad administration and to test whether the protocol is feasible and effective in a typical inpatient stroke health care setting and in the home setting. Thus, the purpose of this project is to conduct a randomized, controlled, multi-site clinical trial, comparing the PA method to a placebo control intervention for the treatment of spatial neglect. The investigators will measure short- and longer-term effectiveness in terms of impairment (i.e., does PA improve neglect symptoms over time), impact on activities of daily living (i.e., foes PA improve independence in daily activities). Feasibility will be measured by overall treatment compliance and patient feedback on usability. This novel PA procedure has the potential to improve patient recovery and quality of life after stroke due to its gamified and portable features that promote treatment accessibility and adherence. The results will help determine if the treatment can be used successfully in inpatient and outpatient settings and who is likely to benefit.
A longitudinal, double-blind, randomized controlled design will be used in the present study. Patients will be randomly assigned (with stratification related to neglect severity) to PA with the use of 15-degree rightward deviating goggles (experimental condition) or PA with the use of 5-degree deviating goggles (placebo control condition). Participants will complete 10, 15-minute training sessions over approximately two weeks. These intervention sessions will involve using a novel and game-like iPad-administered PA procedure called Peg-the-Mole (PTM). Participants will complete the intervention sessions in an inpatient setting or in their homes, depending on their predicted length of hospital stay. A hybrid model will be adopted if a patient is discharged before the intervention is complete. Outcome measures will be collected immediately before, immediately after, and one-month post-treatment and compared between conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spatial Neglect
Keywords
Spatial Neglect, Prism Adaptation, Rehabilitation, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prism adaptation treatment
Arm Type
Experimental
Arm Description
Prism Goggles with 15-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.
Arm Title
Placebo control prism adaptation treatment
Arm Type
Placebo Comparator
Arm Description
Prism goggles with 5-degree rightward deviating prism lenses will be used to maintain the double-blind methodology.
Intervention Type
Behavioral
Intervention Name(s)
Prism Adaptation - 15-degree prism goggles
Intervention Description
Patients in the experimental condition will wear prism goggles while completing an iPad-administered aiming task. The prisms will shift the patients' vision 15 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out for ten sessions for 15 minutes a day, over the span of two weeks.
Intervention Type
Other
Intervention Name(s)
Prism Adaptation - 5-degree prism goggles
Other Intervention Name(s)
Control condition
Intervention Description
5-degree goggles are worn instead of the 15-degree prism goggles, while completing the same tasks as those assigned to the 15-degree condition.
Primary Outcome Measure Information:
Title
Test of neglect severity 1
Description
Change in Behavioural Inattention Test - All conventional subtests (BIT-C)
Time Frame
taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Title
Test of neglect severity 2
Description
Change in after-effects measured by a modified proprioceptive-and-visual straight-ahead outcome task without the use of an occlusion board
Time Frame
measured immediately before and immediately after each intervention session
Title
Test of neglect severity 3
Description
Change in Behavioural Inattention Test - Select behavioural subtests (BIT-B): Article Reading, Menu Reading, and Picture Scanning
Time Frame
taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Title
Test of neglect impact on daily activities
Description
Change in an Eschenbeck Standardized Activities of Daily Living task: Filling out a Form
Time Frame
taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Title
Scale of neglect impact on daily activities
Description
Change in Halifax Neglect Impact Scale
Time Frame
taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Title
Measure of feasibility Measure of feasibility
Description
Treatment compliance with the intervention schedule daily
Time Frame
logged immediately following each intervention session through training logs
Title
Measure of feasibility 2
Description
Patient feedback exit questionnaire
Time Frame
collected immediately after the intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have experienced a right hemisphere stroke (confirmed by a clinician)
Experience mild to severe symptoms of neglect
Be willing and able to consent to participate
Be medically stable
Have self-reported normal to corrected-to-normal vision
Be able to point to targets presented on a computer screen
Live within a two-hour radius of Halifax
Exclusion Criteria:
Other existing neurological disorders (e.g., dementia, multiple sclerosis, epilepsy).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Sophie Champod, PhD
Phone
9028176871
Email
anne.champod@acadiau.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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