Clinical trial NCT04227132: Evaluation of an Adaptive Computerized Training for Rehabilitation of Spatial Neglect in Stroke Survivors
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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Spatial Neglect
Neglect, Hemispatial
Attention Impaired
Cerebrovascular Disorders
Keywords: Neglect
Recovery of function
Rehabilitation
Videogame
Post-stroke
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes at Behavioral Inattention Test (BIT)
timeFrame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
measure: Changes at KF-NAP scale
timeFrame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
Secondary outcomes:
measure: Changes at Load Test
timeFrame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
measure: Changes at Apple Test
timeFrame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
Other outcomes:
Locations:
city: Venice-Lido
country: Italy
facility: Ospedale San Camillo IRCCS
state: Veneto
Study officials:
affiliation: Department of General Psychology, University of Padua, Padua, Italy
name: Marco Zorzi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.