Robotics Plus VR in Improving Cognition

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

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.

Study Overview

• Status: Completed
• Conditions: Cognition Disorders
• Intervention / Treatment: Device: Robotic Treatment plus VR

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98124
    • IRCCS Centro Neurolesi "Bonino-Pulejo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontal Assessment Battery	This is a tool is used to examine global frontal abilities	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial Making Test	This is a tool is used to measure the attention process, and attentive shifting.	3 months

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Investigators: Study Chair: Rocco S Calabrò, IRCCS Centro Neurolesi

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): November 10, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Executive function; Lokomat; VR; Robotic rehab
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: 13/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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