Engaging Mobile Prism Adaptation Treatment at Home

NCT05595668 | Recruiting

• 1 other identifier: EMPATH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Spatial Neglect

Keywords

Spatial Neglect; Prism Adaptation; Rehabilitation; Stroke

Outcome Measures

Primary Outcomes (7)

• Test of neglect severity 1

  Change in Behavioural Inattention Test - All conventional subtests (BIT-C)

  taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention

• 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

  measured immediately before and immediately after each intervention session

• Test of neglect severity 3

  Change in Behavioural Inattention Test - Select behavioural subtests (BIT-B): Article Reading, Menu Reading, and Picture Scanning

  taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention

• Test of neglect impact on daily activities

  Change in an Eschenbeck Standardized Activities of Daily Living task: Filling out a Form

  taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention

• Scale of neglect impact on daily activities

  Change in Halifax Neglect Impact Scale

  taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention

• Measure of feasibility Measure of feasibility

  Treatment compliance with the intervention schedule daily

  logged immediately following each intervention session through training logs

• Measure of feasibility 2

  Patient feedback exit questionnaire

  collected immediately after the intervention

Study Arms (2)

Prism adaptation treatment

EXPERIMENTAL

Prism Goggles with 15-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.

Behavioral: Prism Adaptation - 15-degree prism goggles

Placebo control prism adaptation treatment

PLACEBO COMPARATOR

Prism goggles with 5-degree rightward deviating prism lenses will be used to maintain the double-blind methodology.

Other: Prism Adaptation - 5-degree prism goggles

Interventions

Prism Adaptation - 15-degree prism goggles BEHAVIORAL

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.

Prism adaptation treatment

Prism Adaptation - 5-degree prism goggles OTHER

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.

Also known as: Control condition

Placebo control prism adaptation treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other existing neurological disorders (e.g., dementia, multiple sclerosis, epilepsy).

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (4)

Nova Scotia Health Early Supported Stroke Discharge Team

Bedford, Nova Scotia, B3H 4K4, Canada

RECRUITING

Nova Scotia Rehabilitation and Arthritis Centre (NSRAC)

Halifax, Nova Scotia, B2T 1L7, Canada

NOT YET RECRUITING

Nova Scotia Rehabilitation and Arthritis Centre

Halifax, Nova Scotia, B3H 4K4, Canada

RECRUITING

Valley Regional Hospital

Kentville, Nova Scotia, B4N 5E3, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Anne Sophie Champod, PhD

CONTACT

9028176871; anne.champod@acadiau.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Affiliated Scientist

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 27, 2022
• Study Start: September 15, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)