CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04373837
NCT04373837N/ACompleted

An Innovative Rehabilitation Treatment of Time Deficits in Brain-damaged Patients Combining Prism Adaptation and Virtual Reality

Istituti Clinici Scientifici Maugeri SpA·interventional·Posted May 5, 2020·Updated Sep 29, 2023

In Brief

A clinical study evaluating Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR) and Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR) for Brain Damage. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The efficacy of an innovative rehabilitation treatment for deficit in time processing is tested in right brain damaged patients. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Damage
CountriesItaly

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 5, 2020
Enrollment StartFeb 1, 2018
Primary CompletionMar 20, 2018
Study CompletionJan 13, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.2 years ago

Interventions

Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)behavioral

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)other

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.