ClinicalTrials.Veeva

Menu

Rehabilitation Treatment of Time Deficits in Brain-damaged Patients

I

Istituti Clinici Scientifici Maugeri SpA

Status

Completed

Conditions

Brain Damage

Treatments

Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)

Study type

Interventional

Funder types

Other

Identifiers

NCT04373837
ICS Maugeri CE 2194-Ob2A

Details and patient eligibility

About

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.

Full description

Time processing involves different abilities - i.e. estimating the duration of an event and moving in past and future time - and it is a fundamental ability in everyday life. However, in neuropsychology, time processing is routinely neglected in the assessment of cognitive deficits in brain-damaged patients. This is surprising since time is an important function that permeates our activities: we perceive mismatches in lip reading (milliseconds), we estimate how long it takes to be ready for work (minutes), and we plan how long it will take a manuscript to be accepted (usually months). Thus, impairment in processing time has important consequences in daily life.

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.

Enrollment

20 patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with focal right brain-damage

Exclusion criteria

  • generalized cognitive impairment (score lower than 24 at the Mini Mental State Examination)
  • psychiatric disorders
  • additional neurological disorders
  • abusive use of alcohol or illicit drugs

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Group 1: Without pre - With post
Experimental group
Description:
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).
Treatment:
Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)
Group 2: With pre - Without post
Experimental group
Description:
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).
Treatment:
Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems