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

March 17, 2023 updated by: Marco Zorzi, IRCCS San Camillo, Venezia, Italy

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Veneto
      • Venice-Lido, Veneto, Italy, 30126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
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
Time Frame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
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
Time Frame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
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
Time Frame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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