Virtual Reality and Robot Assisted Gait Training in Patients With Multiple Sclerosis

NCT ID: NCT02896179

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

Brief Summary

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Robot-assisted gait training group+VR

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

GEO

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Nicola Smania, MD, Clinical Professor

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Smania, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Verona, Italy

Countries

Italy

Central Contacts

Alessandro Picelli, MD

Role: CONTACT

aliessandro.picelli@univr.it

+390458124573

Daniele Munari, PT

Role: CONTACT

daniele.munari@univr.it

+390458124573

Facility Contacts

Alessandro Picelli, MD

Role: primary

alessandro.picelli@univr.it

+390458124573

Daniele Munari, PhD

Role: backup

daniele.munari@univr.it

3491025834

Other Identifiers

GE-O-VR

Identifier Type: -

Identifier Source: org_study_id