Clinical trial NCT05595668: Engaging Mobile Prism Adaptation Treatment at Home
Official title: Feasibility and Effectiveness of a New Computerized Treatment Protocol for Spatial Neglect Post Stroke During Inpatient and Outpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spatial Neglect
Keywords: Spatial Neglect
Prism Adaptation
Rehabilitation
Stroke
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Test of neglect severity 1
timeFrame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
measure: Test of neglect severity 2
timeFrame: measured immediately before and immediately after each intervention session
measure: Test of neglect severity 3
timeFrame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
measure: Test of neglect impact on daily activities
timeFrame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
measure: Scale of neglect impact on daily activities
timeFrame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
measure: Measure of feasibility Measure of feasibility
timeFrame: logged immediately following each intervention session through training logs
measure: Measure of feasibility 2
timeFrame: collected immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation and Arthritis Centre (NSRAC)
state: Nova Scotia
Study officials:
References: