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Robotics Plus VR in Improving Cognition

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ClinicalTrials.gov Identifier: NCT03914313
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo"

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.


Condition or disease Intervention/treatment Phase
Cognition Disorders Device: Robotic Treatment plus VR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Robotic Neurorehabilitation Plus Virtual Reality on Attention Process and Executive Functions in Patients With Chronic Stroke: a Randomized Controlled Trial
Actual Study Start Date : April 23, 2019
Actual Primary Completion Date : November 10, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Robotic Treatment plus VR
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat Pro, in which the exoskeleton device is equipped with a VR screen. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). Lokomat will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatment.
Device: Robotic Treatment plus VR
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat-Pro, in which the exoskeleton device is equipped with a screen with virtual reality. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). The Lokomat-Pro will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatment.

Active Comparator: Robotic treatment without VR
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat-Nanos, in which the exoskeleton device is equipped with a screen with a visual feedback (but not virtual reality). The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). The Lokomat-Nanos will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatement.
Device: Robotic Treatment plus VR
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat-Pro, in which the exoskeleton device is equipped with a screen with virtual reality. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). The Lokomat-Pro will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatment.

Active Comparator: Conventional treatment
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a conventional gait rehabilitation. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). Beside conventional overground training for gait, motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatement.
Device: Robotic Treatment plus VR
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat-Pro, in which the exoskeleton device is equipped with a screen with virtual reality. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). The Lokomat-Pro will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatment.




Primary Outcome Measures :
  1. Frontal Assessment Battery [ Time Frame: 3 months ]
    This is a tool is used to examine global frontal abilities


Secondary Outcome Measures :
  1. Trial Making Test [ Time Frame: 3 months ]
    This is a tool is used to measure the attention process, and attentive shifting.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914313


Locations
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Italy
IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, Italy, 98124
Sponsors and Collaborators
IRCCS Centro Neurolesi "Bonino-Pulejo"
Investigators
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Study Chair: Rocco S Calabrò IRCCS Centro Neurolesi
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Responsible Party: Rocco Salvatore Calabrò, Professor, IRCCS Centro Neurolesi "Bonino-Pulejo"
ClinicalTrials.gov Identifier: NCT03914313    
Other Study ID Numbers: 13/19
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo":
Lokomat
Robotic rehab
Executive function
VR
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders