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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Cerebrovascular Disorders; Attention Impaired; Neglect, Hemispatial; Spatial Neglect
• Intervention / Treatment: Device: Adaptive computer game training; Device: Standard computerized training

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesca Meneghello, M.D.; Phone Number: 0039 0412207183; Email: francesca.meneghello@ospedalesancamillo.net

Study Locations

• Italy
  • Veneto
    • Venice-Lido, Veneto, Italy, 30126
      • Recruiting
      • Ospedale San Camillo IRCCS
      • Contact: Daniela D'Imperio, Ph.D.; Phone Number: 0039 0412207183; Email: daniela.dimperio@ospedalesancamillo.net
      • Sub-Investigator: Zaira Romeo, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Labyrinth training, then Standard training; 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; 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.
Experimental: Standard training, then Labyrinth training; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Investigators: Principal Investigator: Marco Zorzi, Ph.D., Department of General Psychology, University of Padua, Padua, Italy

Publications and helpful links

General Publications

• Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Videogame; Post-stroke; Recovery of function; Neglect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Stroke; Cerebrovascular Disorders; Perceptual Disorders
• Other Study ID Numbers: RF-2013-02359306

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No