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

Not Applicable

Recruiting

• Conditions: Stroke; Attention Impaired; Cerebrovascular Disorders; Neglect, Hemispatial; Spatial Neglect

• Registration Number: NCT04227132
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

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.

Study Timeline

• Study Start: 2019-12-16
• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-12-31
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes at Behavioral Inattention Test (BIT)	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
Changes at KF-NAP scale	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

Secondary Outcome Measures

Name	Time	Method
Changes at Load Test	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
Changes at Apple Test	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

Trial Locations

Locations (1)

Ospedale San Camillo IRCCS; 🇮🇹 Venice-Lido, Veneto, Italy