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

IRCCS San Camillo, Venezia, Italy

Status: Enrolling

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

Treatments: Device: Standard computerized training; Device: Adaptive computer game training

Study type: Interventional

Funder types: Other

Identifiers

NCT04227132

RF-2013-02359306

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Labyrinth training, then Standard training

Experimental group

Description:

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.

Treatment:

Device: Adaptive computer game training

Standard training, then Labyrinth training

Experimental group

Description:

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.

Treatment:

Device: Standard computerized training