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

NCT ID: NCT04227132

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adaptive computer game training

Intervention Type: DEVICE

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 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.

Group Type: EXPERIMENTAL

Standard computerized training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role: lead

Responsible Party

Marco Zorzi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Zorzi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of General Psychology, University of Padua, Padua, Italy

Locations

Ospedale San Camillo IRCCS

Venice-Lido, Veneto, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesca Meneghello, M.D.

Role: CONTACT

francesca.meneghello@ospedalesancamillo.net

0412207183 ext. 0039

Facility Contacts

Daniela D'Imperio, Ph.D.

Role: primary

daniela.dimperio@ospedalesancamillo.net

0412207183 ext. 0039

References

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.

Reference Type: DERIVED

PMID: 34196963 (View on PubMed)

Other Identifiers

RF-2013-02359306

Identifier Type: -

Identifier Source: org_study_id