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

Multiple Sclerosis Clinical Trial

— GE-O-VR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02896179
• Other study ID #: GE-O-VR
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2016
• Last updated: September 22, 2016
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: September 2016
• Source: Universita di Verona
• Contact: Alessandro Picelli, MD
• Phone: +390458124573
• Email: aliessandro.picelli[@]univr.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Azienta Ospedaliera, SSO Rehabilitation Unit, Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Berg Balance Scale		Baseline time 0 and up to 12 weeks	Yes
Secondary	2-Minute Walking Test (meters)		Baseline time 0 and up to 12 weeks	Yes
Secondary	Activities-specific Balance Confidence Scale		Baseline time 0 and up to 12 weeks	Yes
Secondary	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	Yes
Secondary	Multiple Sclerosis Quality Of Life-54		Baseline time 0 and up to 12 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Phonemic Fluency Test		Baseline time 0 and up to 12 weeks	Yes
Secondary	Paced Auditory Serial Addition Test		Baseline time 0 and up to 12 weeks	Yes
Secondary	Trail Making Test		Baseline time 0 and up to 12 weeks	Yes
Secondary	Wechsler Adult Intelligence Scale		Baseline time 0 and up to 12 weeks	Yes