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Robotics Plus VR in Improving Cognition

Primary Purpose

Cognition Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Robotic Treatment plus VR
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition Disorders focused on measuring Lokomat, Robotic rehab, Executive function, VR

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Robotic Treatment plus VR

Robotic treatment without VR

Conventional treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Frontal Assessment Battery
This is a tool is used to examine global frontal abilities

Secondary Outcome Measures

Trial Making Test
This is a tool is used to measure the attention process, and attentive shifting.

Full Information

First Posted
April 11, 2019
Last Updated
January 21, 2020
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT03914313
Brief Title
Robotics Plus VR in Improving Cognition
Official Title
Effects of Robotic Neurorehabilitation Plus Virtual Reality on Attention Process and Executive Functions in Patients With Chronic Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders
Keywords
Lokomat, Robotic rehab, Executive function, VR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic Treatment plus VR
Arm Type
Experimental
Arm Description
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.
Arm Title
Robotic treatment without VR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic Treatment plus VR
Intervention Description
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 Measure Information:
Title
Frontal Assessment Battery
Description
This is a tool is used to examine global frontal abilities
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Trial Making Test
Description
This is a tool is used to measure the attention process, and attentive shifting.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocco S Calabrò
Organizational Affiliation
IRCCS Centro Neurolesi
Official's Role
Study Chair
Facility Information:
Facility Name
IRCCS Centro Neurolesi "Bonino-Pulejo"
City
Messina
ZIP/Postal Code
98124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Robotics Plus VR in Improving Cognition

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