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Clinical Trials/NCT03914313
NCT03914313
Completed
Not Applicable

Effects of Robotic Neurorehabilitation Plus Virtual Reality on Attention Process and Executive Functions in Patients With Chronic Stroke: a Randomized Controlled Trial

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country90 target enrollmentApril 23, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognition Disorders
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
90
Locations
1
Primary Endpoint
Frontal Assessment Battery
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Stroke can be classified as ischemic, i.e. due to the lack of blood flow, and haemorrhagic, caused by bleeding. Stroke results in focal signs and symptoms, with a devastating impact on a patient and his family. Although robotic rehabilitation is very useful in improving motor function, there is no a clear evidence on its role in improving cognitive abilities, which are often compromised in stroke patients.

To this end, the investigators designed a randomized controlled experimental study on stroke patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat with and without virtual reality on cognitive functioning in stroke patients, compared to traditional therapy.

Registry
clinicaltrials.gov
Start Date
April 23, 2019
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rocco Salvatore Calabrò

Professor

IRCCS Centro Neurolesi "Bonino-Pulejo"

Eligibility Criteria

Inclusion Criteria

  • Neurological diagnosis of stroke in the post-acute phase (3 months from the acute event); age between 40 and 80; and Caucasian ethnicity; a FIM motor score equal to or greater than 30 and moderate to mild cognitive impairment (MoCA\> 18); Fugl-Meyer scale score of\> 18;

Exclusion Criteria

  • Patients with a history of concomitant neurodegenerative diseases or brain surgery; severe cognitive or language impairment; systemic, bone or joint disorders; presence of disabling sensory alterations; concomitant medical and psychiatric illness that could interfere with VR training.

Outcomes

Primary Outcomes

Frontal Assessment Battery

Time Frame: 3 months

This is a tool is used to examine global frontal abilities

Secondary Outcomes

  • Trial Making Test(3 months)

Study Sites (1)

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