search
Back to results

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
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. Have experienced a right hemisphere stroke (confirmed by a clinician)
  2. Experience mild to severe symptoms of neglect
  3. Be willing and able to consent to participate
  4. Be medically stable
  5. Have self-reported normal to corrected-to-normal vision
  6. Be able to point to targets presented on a computer screen
  7. 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

    First Posted
    October 14, 2022
    Last Updated
    October 26, 2022
    Sponsor
    Nova Scotia Health Authority
    search

    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

    Learn more about this trial

    Engaging Mobile Prism Adaptation Treatment at Home

    We'll reach out to this number within 24 hrs