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

NCT04227132 | Unknown DMC

• 1 other identifier: RF-2013-02359306
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Neglect; Recovery of function; Rehabilitation; Videogame; Post-stroke

Outcome Measures

Primary Outcomes (2)

• Changes at Behavioral Inattention Test (BIT)

  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

  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 Outcomes (2)

• 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

• 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

Study Arms (2)

Labyrinth training, then Standard training

EXPERIMENTAL

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

Standard training, then Labyrinth training

EXPERIMENTAL

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

Interventions

Adaptive computer game training 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.

Labyrinth training, then Standard training

Standard computerized training 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.

Standard training, then Labyrinth training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Prior history of psychiatric or neurological disease
• Substance abuse
• Inability to sustain the experimental trainings

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

Ospedale San Camillo IRCCS

Venice-Lido, Veneto, 30126, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 34196963 DERIVED

MeSH Terms

Conditions

Stroke; Perceptual Disorders; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Zorzi, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Meneghello, M.D.

CONTACT

0412207183; francesca.meneghello@ospedalesancamillo.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 13, 2020
• Study Start: December 16, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 1, 2025
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

IT (1)