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

NCT02896179 | Unknown DMC

• 1 other identifier: GE-O-VR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Multiple sclerosis; Gait rehabilitation; Quality of life; Virtual reality; Cognitive deficit; Robot assisted gait training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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

  Baseline time 0 and up to 12 weeks

• Multiple Sclerosis Quality Of Life-54

  Baseline time 0 and up to 12 weeks

Study Arms (2)

Robot-assisted gait training group+VR

EXPERIMENTAL

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

Robot-assisted gait training group

ACTIVE COMPARATOR

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

Interventions

Robot-assisted gait training group+VR 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+VR

GEO 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

Robot-assisted gait training group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Verona, 37134, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognition Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Picelli, MD

CONTACT

+390458124573; aliessandro.picelli@univr.it

Daniele Munari, PT

CONTACT

+390458124573; daniele.munari@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 12, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: September 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)