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

Stroke Clinical Trial

— MULTITASK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04227132
• Other study ID #: RF-2013-02359306
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Francesca Meneghello, M.D.
• Phone: 0412207183
• Email: francesca.meneghello[@]ospedalesancamillo.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Impaired
• Cerebrovascular Disorders
• Neglect, Hemispatial
• Perceptual Disorders
• Spatial Neglect
• Stroke

Intervention

Device:
• Adaptive computer game training
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.
• Standard computerized training
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.

Locations

Country	Name	City	State
Italy	Ospedale San Camillo IRCCS	Venice-Lido	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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