StrokeMULTITASKNCT04227132
Evaluation of an Adaptive Computerized Training for Rehabilitation of Spatial Neglect in Stroke Survivors
A study testing Adaptive computer game training and Standard computerized training in people with Stroke and Spatial Neglect, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spatial Neglect, Neglect, Hemispatial
- What is being tested?
- Adaptive computer game training and Standard computerized training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Prior history of psychiatric or neurological disease
- Substance abuse
- Inability to sustain the experimental trainings
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Camillo IRCCS
Venice-Lido, Veneto, 30126
Daniela D'Imperio, Ph.D., 0412207183 ext. 0039, daniela.dimperio@ospedalesancamillo.net
Zaira Romeo, Ph.D.
About this study
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
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.
Read the 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
- Being tested
- Adaptive computer game training, Standard computerized training
- Keywords
- Neglect, Recovery of function, Rehabilitation, Videogame, Post-stroke
- Medical subject headings
- Stroke, Perceptual Disorders, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive computer game trainingDevice
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 computerized trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes at Behavioral Inattention Test (BIT)
Diagnostic test for spatial neglect, composed by different subtests of spatial attention
Measured: 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
Measured: 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
Computerized test on spatial monitoring and multitasking abilities
Measured: 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
Test for allocentric and egocentric spatial neglect
Measured: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start16 Dec 2019
- Primary completion31 Dec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Zorzi, University of Padova
- Investigators
- Marco Zorzi, Ph.D., Principal investigator, Department of General Psychology, University of Padua, Padua, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227132
- Sponsor's protocol ID
- RF-2013-02359306
- Acronym
- MULTITASK
- Status last verified
- Mar 2023
- First submitted
- 31 Dec 2019
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34196963
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04227132
- Acronym / sponsor ID
- MULTITASK / RF-2013-02359306
- Conditions
- Stroke, Spatial Neglect, Neglect, Hemispatial, Attention Impaired, Cerebrovascular Disorders
- Keywords
- Neglect, Recovery of function, Rehabilitation, Videogame, Post-stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Labyrinth training, then Standard training | Experimental | Device: Adaptive computer game trainingPatients 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. |
| Standard training, then Labyrinth training | Experimental | Device: Standard computerized trainingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Prior history of psychiatric or neurological disease
- Substance abuse
- Inability to sustain the experimental trainings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive computer game trainingPatients 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. | Device | Labyrinth training, then Standard training |
| Standard computerized trainingPatients 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. | Device | Standard training, then Labyrinth training |
Primary outcome
Changes at Behavioral Inattention Test (BIT)
Time frame: 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
Time frame: 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
2 secondary outcomes
Changes at Load Test
Time frame: 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
Time frame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 34196963Longley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Zorzi, Ph.D. principal investigator
Department of General Psychology, University of Padua, Padua, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive computer game training and Standard computerized training in people with Stroke and Spatial Neglect, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Meneghello, M.D. (0412207183 ext. 0039, francesca.meneghello@ospedalesancamillo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes at Behavioral Inattention Test (BIT) (time frame: Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04227132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.