Clinical trial NCT02896179: Virtual Reality and Robot Assisted Gait Training in Patients With Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Gait rehabilitation
Quality of life
Virtual reality
Cognitive deficit
Robot assisted gait training
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 10 meters Walking test (10-MtWT) change in gait speed (m/sec)
timeFrame: Baseline time 0 and up to 12 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline time 0 and up to 12 weeks
measure: 2-Minute Walking Test (meters)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Baseline time 0 and up to 12 weeks
measure: Tower of London - point
timeFrame: Baseline time 0 and up to 12 weeks
measure: Multiple Sclerosis Quality Of Life-54
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - Cadence (step/min)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - Stride length (cm)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - Step length (cm)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - distance of heel to heel (cm)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - time of stance (sec)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - time of swing (sec)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - time of single support (sec)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Gait Analysis - time of double support (sec)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Body's Centre of Pressure length (mm)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Body's Centre of Pressure Area Path (mm2)
timeFrame: Baseline time 0 and up to 12 weeks
measure: Sustained Attention to Response Task - Time of reaction time
timeFrame: Baseline time 0 and up to 12 weeks
measure: Phonemic Fluency Test
timeFrame: Baseline time 0 and up to 12 weeks
measure: Paced Auditory Serial Addition Test
timeFrame: Baseline time 0 and up to 12 weeks
measure: Trail Making Test
timeFrame: Baseline time 0 and up to 12 weeks
measure: Wechsler Adult Intelligence Scale
timeFrame: Baseline time 0 and up to 12 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Study officials:
affiliation: 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
name: Nicola Smania, MD
role: PRINCIPAL_INVESTIGATOR
References: