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

Primary Purpose

Stroke, Spatial Neglect, Neglect, Hemispatial

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Adaptive computer game training
Standard computerized training
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Neglect, Recovery of function, Rehabilitation, Videogame, Post-stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ospedale San Camillo IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Labyrinth training, then Standard training

Standard training, then Labyrinth training

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes at Behavioral Inattention Test (BIT)
Diagnostic test for spatial neglect, composed by different subtests of spatial attention
Changes at KF-NAP scale
Test for everyday functional outcome

Secondary Outcome Measures

Changes at Load Test
Computerized test on spatial monitoring and multitasking abilities
Changes at Apple Test
Test for allocentric and egocentric spatial neglect

Full Information

First Posted
December 31, 2019
Last Updated
March 17, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT04227132
Brief Title
Evaluation of an Adaptive Computerized Training for Rehabilitation of Spatial Neglect in Stroke Survivors
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spatial Neglect, Neglect, Hemispatial, Attention Impaired, Cerebrovascular Disorders
Keywords
Neglect, Recovery of function, Rehabilitation, Videogame, Post-stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking Description
Patients will be informed to take part in an experimental study on the rehabilitation of attention delivered through a computer game. Specific information about the rationale of the study will not be conveyed to patients. Both trainings will be administered, with the aim to support patients' autonomy in performance.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Labyrinth training, then Standard training
Arm Type
Experimental
Arm 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.
Arm Title
Standard training, then Labyrinth training
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Adaptive computer game training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard computerized training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes at Behavioral Inattention Test (BIT)
Description
Diagnostic test for spatial neglect, composed by different subtests of spatial attention
Time Frame
Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
Title
Changes at KF-NAP scale
Description
Test for everyday functional outcome
Time Frame
Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
Secondary Outcome Measure Information:
Title
Changes at Load Test
Description
Computerized test on spatial monitoring and multitasking abilities
Time Frame
Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
Title
Changes at Apple Test
Description
Test for allocentric and egocentric spatial neglect
Time Frame
Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Meneghello, M.D.
Phone
0412207183
Ext
0039
Email
francesca.meneghello@ospedalesancamillo.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Zorzi, Ph.D.
Organizational Affiliation
Department of General Psychology, University of Padua, Padua, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Camillo IRCCS
City
Venice-Lido
State/Province
Veneto
ZIP/Postal Code
30126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela D'Imperio, Ph.D.
Phone
0412207183
Ext
0039
Email
daniela.dimperio@ospedalesancamillo.net
First Name & Middle Initial & Last Name & Degree
Zaira Romeo, Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
34196963
Citation
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.
Results Reference
derived

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

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