Rehabilitation Treatment of Time Deficits in Brain-damaged Patients
NCT ID: NCT04373837
Last Updated: 2023-09-29
Study Results
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Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-02-01
2023-01-13
Brief Summary
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Patients with a focal lesion following a stroke and without general cognitive impairment will be submitted to computerized tests assessing the ability to estimate time duration (intervals around 7500 ms) and to mental travel in time. Moreover, the impact of the deficit in time processing in everyday life will be evaluated by using ad hoc questionnaires.
Patients will perform tasks before and after two weeks of a new rehabilitation treatment, combining a training for one week with prismatic googles inducing prismatic adaptation (PA) plus Virtual Reality (VR) and a training for one week with neutral googles inducing no-adaptation (NA) plus Virtual Reality. Participants will be randomized into two groups. Each group will be submitted to both treatments in a different order, accordingly with a crossover design.
A greater amelioration in time processing after PA+VR than NA+VR training should be found. Moreover, an improvement in everyday life activities is expected accordingly with the amelioration in time processing.
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Detailed Description
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For instance, it is known that right brain damaged (RBD) patients with spatial attentional deficit (neglect) are impaired in estimate the duration of a time interval as well as in the ability of mentally moving in time (Mental Time Travelling).
Previous studies have demonstrated an improvement of time estimation and mental time travel after a leftward shift of spatial attention induced by a single session of prismatic adaptation (PA). Moreover, a recent study investigated the long-term duration of the benefits induced by 10 daily sessions of PA treatment on mental time travel and functional abilities in neglect patients. Results suggest that the PA treatment induces a long-lasting and stable ameliorations of mental time travel and functional competences.
To generalize the effects of PA treatment to everyday life, here we propose to combine PA with a virtual reality training (VR). VR has recently been used as an effective tool both for the assessment and rehabilitation of cognitive deficits, because it allows post-stroke patients to interact with ecological environments similar to the real ones, but in a safe and controlled condition.
Aim of this study is to set up a rehabilitation procedure for temporal deficits, combining a well-established PA procedure with an innovative, more engaging and ecological VR approach.
Patients will perform tasks before and after two weeks of a new rehabilitation treatment, combining a training for one week with prismatic googles inducing prismatic adaptation (PA) plus Virtual Reality (VR) and a training for one week with neutral googles inducing no-adaptation (NA) plus Virtual Reality. Participants will be randomized into two groups. Each group will be submitted to both treatments in a different order, accordingly with a crossover design.
A greater amelioration in time processing after PA+VR than NA+VR training should be found. Moreover, an improvement in everyday life activities is expected accordingly with the amelioration in time processing.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1: Without pre - With post
Patients will perform two weeks treatment (10 sessions in total). First week: 5 days/week for 1 week, a daily session of pointing with neutral goggles inducing no-adaptation (NA) + Virtual Reality (VR) task (5 sessions).
Second week: 5 days/week for 1 week, a daily session of pointing with prismatic goggles inducing prismatic adaptation (PA) + VR task (5 sessions).
Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)
The experimental condition consists of PA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a rightward shift of the visual field (experimental condition). After lenses removal, a leftward shift of spatial attention will be produced.
Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
The sham condition of this study consists of NA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with neutral goggles (control condition), which should not induce a shift of the visual field and of spatial attention.
Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
Group 2: With pre - Without post
Patients will perform two weeks treatment (10 sessions in total). First week: 5 days/week for 1 week, a daily session of pointing with prismatic goggles inducing prismatic (PA) + Virtual Reality (VR) task (5 sessions).
Second week: 5 days/week for 1 week, a daily session of pointing with neutral goggles inducing no-adaptation (NA) + VR task (5 sessions).
Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)
The experimental condition consists of PA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a rightward shift of the visual field (experimental condition). After lenses removal, a leftward shift of spatial attention will be produced.
Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
The sham condition of this study consists of NA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with neutral goggles (control condition), which should not induce a shift of the visual field and of spatial attention.
Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
Interventions
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Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)
The experimental condition consists of PA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a rightward shift of the visual field (experimental condition). After lenses removal, a leftward shift of spatial attention will be produced.
Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
The sham condition of this study consists of NA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with neutral goggles (control condition), which should not induce a shift of the visual field and of spatial attention.
Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* psychiatric disorders
* additional neurological disorders
* abusive use of alcohol or illicit drugs
45 Years
85 Years
ALL
No
Sponsors
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University of Bologna
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
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Principal Investigators
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Francesca Frassinetti, PhD
Role: PRINCIPAL_INVESTIGATOR
Istituti Clinici Scientifici Maugeri IRCCS
Locations
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ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero funzionale di Castel Goffredo
Castel Goffredo, Mantova, Italy
Countries
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References
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Anelli F, Avanzi S, Arzy S, Mancuso M, Frassinetti F. Effects of spatial attention on mental time travel in patients with neglect. Cortex. 2018 Apr;101:192-205. doi: 10.1016/j.cortex.2018.01.012. Epub 2018 Feb 2.
Anelli F, Avanzi S, Damora A, Mancuso M, Frassinetti F. Mental time travel and functional daily life activities in neglect patients: Recovery effects of rehabilitation by prism adaptation. Cortex. 2019 Apr;113:141-155. doi: 10.1016/j.cortex.2018.12.003. Epub 2018 Dec 14.
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Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297.
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Linacre JM, Heinemann AW, Wright BD, Granger CV, Hamilton BB. The structure and stability of the Functional Independence Measure. Arch Phys Med Rehabil. 1994 Feb;75(2):127-32.
Mancuso M, Rosadoni S, Capitani D, Bickerton WL, Humphreys GW, De Tanti A, Zampolini M, Galardi G, Caputo M, De Pellegrin S, Angelini A, Bartalini B, Bartolo M, Carboncini MC, Gemignani P, Spaccavento S, Cantagallo A, Zoccolotti P, Antonucci G. Italian standardization of the Apples Cancellation Test. Neurol Sci. 2015 Jul;36(7):1233-40. doi: 10.1007/s10072-015-2088-2. Epub 2015 Jan 25.
Oliveri M, Magnani B, Filipelli A, Avanzi S, Frassinetti F. Prismatic adaptation effects on spatial representation of time in neglect patients. Cortex. 2013 Jan;49(1):120-30. doi: 10.1016/j.cortex.2011.11.010. Epub 2011 Nov 27.
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Other Identifiers
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ICS Maugeri CE 2194-Ob2A
Identifier Type: -
Identifier Source: org_study_id
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