Virtual Reality and Robot Assisted Gait Training in Patients With Multiple Sclerosis (GE-O-VR)

The Effects of an Innovative Combined Virtual Reality and Robot Assisted Gait Training on Cognitive and Walking Functions in Patients With Multiple Sclerosis: A Randomized Control Trial

Multiple Sclerosis (MS), the most common non-traumatic cause of neurologic disability in young adults, affects mobility and ambulation in the majority of patients. Nearly 50% of persons with MS will require an assistive device to ambulate within 10 years of diagnosis. A subgroup of MS is Primary Progressive MS, which manifests with gait disturbances over 80% of patients in the long term. In addition to altered gait, nearly 70% of patients will experience cognitive deficits during the course of the disease. Therefore, actions that facilitate patient involvement in finding solutions for personalized management of disease and disability are needed.

Although immunomodulatory drugs offer some benefit in other types of Multiple Sclerosis, there is currently no effective treatment for Primary Progressive MS. A fundamental goal in the management of persons with MS is to maximize their ability to ambulate and perform safe and effective transfers in everyday life.

In the last decade, research has increasingly centered on the effects of robot devices in the rehabilitation of patients with neurological diseases. This has led to the development of new robot-assisted gait devices engendered by virtual-reality systems, and several studies have demonstrated the positive effects that these devices have on gait endurance and quality of life in patients with neurological diseases and disability.

The aim of this project is to develop and study the effects of a novel, cognitively intensive virtual-reality -based rehabilitation software application that simulates a real-world environment where a person can walk. The virtual-reality application is an upgrade version synchronized to a robotic device, the GEO System. The second aim is to compare the cognitive and motor effects of robot-assisted gait training with this application against training with robot-assisted gait training without virtual reality.

The experimental group will receive robot-assisted gait training with the virtual-reality application and the control group will receive robot-assisted gait training All subjects will undergo training for 6 weeks (2 sessions/week) for a total of 12 sessions. Assessments before training, after training, and at follow-up will be performed using clinical and instrumental tests to compare the effects of training.

Successful completion of the study may help patients to alleviate the impact of disability, increase their independence in activities of daily life, and improve their quality of life. Through new rehabilitative strategies that combine cognitive and motor training involving higher brain functions and motivation, patients will be stimulated to walk in a reality-based environment.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Robot-assisted gait training group+VR; Device: GEO

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Expanded Disability Status Scale between 3 and 6;
• Mini Mental Examination State >24;
• age >18 years;
• ability to sit without trunk support;
• ability to stand for at least 10 seconds with support;
• no botulinum toxin injection into the affected leg muscles or rehabilitation treatment in the 6 months before recruitment.

Exclusion Criteria:

• patients with disease recurrence that has worsened significantly during the 8 weeks before recruitment;
• changes in pharmacological therapy that could modify the disease course in the previous 3 months before recruitment;
• changes in pharmacological therapy for fatigue treatment in the previous 3 months before recruitment
• medications altering central nervous system (excitability (e.g., antiepileptics, neuroleptics, benzodiazepines or antidepressants) or with presumed effects on central nervous system plasticity (e.g., dopamine, fluoxetine or D-amphetamine);
• other neurological or orthopedic conditions involving the lower limbs (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, joint replacement);
• cardiovascular co-morbidity (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted gait training group+VR; The first group will be subjected to Robot-assisted gait training (RAGT) for 6 weeks (2 sessions/ week) with a total of 12 sessions by mean of GEO System plus Virtual Reality scenario. During each session, the patients will practice 15 to 20 min of simulated floor walking with simulating of a real walking trail. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.	Device: Robot-assisted gait training group+VR; The first group will be subjected to Robot-assisted gait training (RAGT) for 6 weeks (2 sessions/ week) with a total of 12 sessions by mean of GEO System plus Virtual Reality scenario. During each session, the patients will practice 15 to 20 min of simulated floor walking with simulating of a real walking trail. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.
Active Comparator: Robot-assisted gait training group; The second group will be subjected to Robot-assisted gait training (RAGT) for 6 weeks (2 sessions/ week) with a total of 12 sessions by mean of GEO System. During each session, the patients will practice 15 to 20 min of simulated floor walking. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.	Device: GEO; The second group will be subjected to Robot-assisted gait training (RAGT) for 6 weeks (2 sessions/ week) with a total of 12 sessions by mean of GE-O System. During each session, the patients will practice 15 to 20 min of simulated floor walking. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 meters Walking test (10-MtWT) change in gait speed (m/sec)	the test has been selected as a measure of gait speed. This is a validated test requiring individuals to walk on a flat hard floor at their fastest speed for 10 meters. Scoring is walking speed.	Baseline time 0 and up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale		Baseline time 0 and up to 12 weeks
2-Minute Walking Test (meters)		Baseline time 0 and up to 12 weeks
Activities-specific Balance Confidence Scale		Baseline time 0 and up to 12 weeks
Tower of London - point	Tower of London assesses deficits in planning abilities and strategic problem solving. Two pictures are shown to the subject. Each picture shows three different colored balls arranged in different positions on three pegs. The subject has to transpose the three balls, starting from an initial position, to reach various final positions in a specific number of moves. The task comprises 12 problems with different target positions. For each problem, the participant earns three points if a solution is reached in only one attempt, two points if the solution is reached in two attempts, one point if the solution is reached in three attempts, and zero points if the solution is not reached in three attempts (range 0-36; higher scores=better performance)	Baseline time 0 and up to 12 weeks
Multiple Sclerosis Quality Of Life-54		Baseline time 0 and up to 12 weeks
Gait Analysis - Cadence (step/min)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Gait Analysis - Stride length (cm)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Gait Analysis - Step length (cm)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Gait Analysis - distance of heel to heel (cm)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Gait Analysis - time of stance (sec)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Gait Analysis - time of swing (sec)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Gait Analysis - time of single support (sec)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Gait Analysis - time of double support (sec)	It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.	Baseline time 0 and up to 12 weeks
Body's Centre of Pressure length (mm)	the static balance will be carried out with a monaxial platform, an electronic system used for the evaluation of the length of the centre of pressure (CoP)	Baseline time 0 and up to 12 weeks
Body's Centre of Pressure Area Path (mm2)	the static balance will be carried out with a monaxial platform, an electronic system used for the evaluation of the length of the centre of pressure (CoP)	Baseline time 0 and up to 12 weeks
Sustained Attention to Response Task - Time of reaction time	evaluates sustained attention, response inhibition, and reaction time. It is a go-no go target detection task composed of a series of numbers containing different digits from 1 to 9. The subject has to respond as quickly as possible to the appearance of each number by pressing a button, except when the number is 3. The score is the reaction times averaged over the test, and the total number of correct and incorrect responses	Baseline time 0 and up to 12 weeks
Phonemic Fluency Test		Baseline time 0 and up to 12 weeks
Paced Auditory Serial Addition Test		Baseline time 0 and up to 12 weeks
Trail Making Test		Baseline time 0 and up to 12 weeks
Wechsler Adult Intelligence Scale		Baseline time 0 and up to 12 weeks

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Nicola Smania, MD, Neuromotor and Cognitive Rehabilitation Center Department of Neurological and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Quality of life; Multiple sclerosis; Virtual reality; Gait rehabilitation; Cognitive deficit; Robot assisted gait training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: GE-O-VR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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