Evaluation of an Adaptive Computerized Training for Rehabilitation of Spatial Neglect in Stroke Survivors

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of training with an adaptive computer game, in comparison to standard training, in the rehabilitation of stroke survivors suffering from spatial neglect.

Detailed Description
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Many stroke survivors who have suffered right brain damage show spatial neglect (SN), a deficit of spatial attention orienting that causes unawareness for stimuli located in the left hemispace. Recent data show that the execution of concurrent tasks (that is, multitasking) can worsen the clinical condition and impact functional recovery. The aim of this study is to investigate the effect of an adaptive computer game Labyrinth previously validated on health population. The videogame is designed for training both attention and execution functions as it engages spatial navigation and multitasking. The effect of the computer game will be compared to standard computerized exercises used for neglect rehabilitation. The investigators plan to administer to a sample of 30 stroke patients with SN both Labyrinth and standard trainings for 10 sessions each. The two trainings will be delivered in a randomized crossover design. Improvements of patients' performance will be registered across trainings and in a follow-up test at 1 month, by assessing the severity of SN and functional everyday outcomes. The investigators expect that patients' performance will improve following both types of training, but with stronger improvement for the adaptive videogame.

Official Title
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Modulation of Visuospatial Awareness During Multi-tasking in Right Hemisphere Stroke Patients: Towards Novel Behavioural and Neurofunctional Predictors of Impairments and Recovery of the Attentional Networks

Conditions
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Stroke, Spatial Neglect, Neglect, Hemispatial, Attention Impaired, Cerebrovascular Disorders

Intervention / Treatment
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* Device: Adaptive computer game training
* Device: Standard computerized training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First stroke patients with right brain damage Right-handed Preserved Italian language comprehension to provide informed consensus Clinical signs of spatial neglect (diagnosis by BIT) Exclusion Criteria: Prior history of psychiatric or neurological disease Substance abuse Inability to sustain the experimental trainings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Both experimental and control trainings will be administered consecutively to all patients. Each type of training will be delivered for 10 sessions, with order of training randomized across participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Labyrinth training, then Standard training<br>Patients will receive at first the Labyrinth training for 10 sessions of 45 minutes, delivered 4 days per week. The, they will undergo the Standard training for 10 sessions of 45 minutes, for around 4 days per week. Before and after each training patients are tested for primary and secondary outcomes with standardized tests. | Device: Adaptive computer game training<br>* Patients sit in front of a computer monitor and play the adaptive videogame with a joystick. The game requires to orient and move inside a maze, and it includes phases that engage multitasking abilities. The level and speed of the game is adapted online to patients' performance.<br>|
| Experimental: Standard training, then Labyrinth training<br>Patients will receive at first the Standard training for 10 sessions of 45 minutes, delivered 4 days per week. Then they will undergo the Labyrinth training for 10 sessions of 45 minutes, for around 4 days per week. Before and after each training patients are tested for primary and secondary outcomes with standardized tests. | Device: Standard computerized training<br>* Patients sit in front of the computer monitor and perform simple computerized exercises using a keyboard to respond. Exercises are organized into modules according to the trained cognitive functions. Patients will perform four different modules that are designed for neglect rehabilitation. The level of exercises adapts periodically based on patient's performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes at Behavioral Inattention Test (BIT) | Diagnostic test for spatial neglect, composed by different subtests of spatial attention | Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training | 
| Changes at KF-NAP scale | Test for everyday functional outcome | Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes at Load Test | Computerized test on spatial monitoring and multitasking abilities | Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training | 
| Changes at Apple Test | Test for allocentric and egocentric spatial neglect | Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Videogame, Neglect, Recovery of function, Rehabilitation, Post-stroke