Early Neurocognitive Rehabilitation in Intensive Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-09-30

Brief Summary

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The purpose of this project is to assess the efficacy of an early neurocognitive intervention for ICU patients, in terms of psychopathological, neuropsychological and functional improvement. The treatment is supported in an interactive advanced computing platform that includes the continuous biomedical registration of the patients and a virtual reality software specifically designed for critical patients.

The investigators expect an improvement in neuropsychological, psychopathological and functional status at hospital discharge and 3 months follow-up in those patients that have received the early neurocognitive intervention comparing with patients treated as usual. Furthermore the investigators expect a decrease of episodes and/or duration of delirium in ICU patients.

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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neurocognitive stimulation

Intervention of experimental group consists in a neurocognitive stimulation treatment. Using kinect technology, patient can interact with a virtual environment where different cognitive tasks have to be resolved.

Group Type EXPERIMENTAL

Neurocognitive stimulation

Intervention Type OTHER

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neurocognitive stimulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged between 18 and 80 years
* Patients receiving mechanical ventilation for at least 24 hours
* Patients scoring more than 8 on the Glasgow Coma Scale (GCS) and more than 2 on the Sedation Agitation Scale (SAS)
* Patients haemodynamically stable
* Informed consent signed by the closest relatives.

Exclusion Criteria

* Patients with previous neurologic pathology or focal brain injury before ICU admission
* Patients with serious psychiatric pathology (major depression, psychosis, bipolar disease) or mentally retarded
* Patients with sensorial alterations needed to interact with the neurocognitive stimulation programme
* patients whose closest relatives refuse the subject to be included in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No