Multiple SclerosisGE-O-VRNCT02896179
Virtual Reality and Robot Assisted Gait Training in Patients With Multiple Sclerosis
A study testing Robot-assisted gait training group+VR and GEO in people with Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Robot-assisted gait training group+VR and GEO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Verona, Verona, 37134
Alessandro Picelli, MD, +390458124573, alessandro.picelli@univr.it
Daniele Munari, PhD, 3491025834, daniele.munari@univr.it
About this study
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
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.
Read more
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
- Being tested
- Robot-assisted gait training group+VR, GEO
- Keywords
- Multiple sclerosis, Gait rehabilitation, Quality of life, Virtual reality, Cognitive deficit, Robot assisted gait training
- Medical subject headings
- Multiple Sclerosis, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted gait training group+VRDevice
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.
GEODevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: GEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline time 0 and up to 12 weeks
Secondary outcomes (20)
Berg Balance Scale
Measured: Baseline time 0 and up to 12 weeks
2-Minute Walking Test (meters)
Measured: Baseline time 0 and up to 12 weeks
Activities-specific Balance Confidence Scale
Measured: 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)
Measured: Baseline time 0 and up to 12 weeks
Multiple Sclerosis Quality Of Life-54
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline time 0 and up to 12 weeks
Phonemic Fluency Test
Measured: Baseline time 0 and up to 12 weeks
Paced Auditory Serial Addition Test
Measured: Baseline time 0 and up to 12 weeks
Trail Making Test
Measured: Baseline time 0 and up to 12 weeks
Wechsler Adult Intelligence Scale
Measured: Baseline time 0 and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
- Investigators
- Nicola Smania, MD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896179
- Sponsor's protocol ID
- GE-O-VR
- Acronym
- GE-O-VR
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02896179
- Acronym / sponsor ID
- GE-O-VR / GE-O-VR
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Gait rehabilitation, Quality of life, Virtual reality, Cognitive deficit, Robot assisted gait training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted gait training group+VR | Experimental | Device: Robot-assisted gait training group+VRThe 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 | Active comparator | Device: GEOThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted gait training group+VRThe 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 |
| GEOThe 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 | Device | Robot-assisted gait training group |
Primary outcome
10 meters Walking test (10-MtWT) change in gait speed (m/sec)
Time frame: Baseline time 0 and up to 12 weeks
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.
20 secondary outcomes
Berg Balance Scale
Time frame: Baseline time 0 and up to 12 weeks
2-Minute Walking Test (meters)
Time frame: Baseline time 0 and up to 12 weeks
Activities-specific Balance Confidence Scale
Time frame: Baseline time 0 and up to 12 weeks
Tower of London - point
Time frame: Baseline time 0 and up to 12 weeks
Multiple Sclerosis Quality Of Life-54
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - Cadence (step/min)
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - Stride length (cm)
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - Step length (cm)
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - distance of heel to heel (cm)
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - time of stance (sec)
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - time of swing (sec)
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - time of single support (sec)
Time frame: Baseline time 0 and up to 12 weeks
Gait Analysis - time of double support (sec)
Time frame: Baseline time 0 and up to 12 weeks
Body's Centre of Pressure length (mm)
Time frame: Baseline time 0 and up to 12 weeks
Body's Centre of Pressure Area Path (mm2)
Time frame: Baseline time 0 and up to 12 weeks
Sustained Attention to Response Task - Time of reaction time
Time frame: Baseline time 0 and up to 12 weeks
Phonemic Fluency Test
Time frame: Baseline time 0 and up to 12 weeks
Paced Auditory Serial Addition Test
Time frame: Baseline time 0 and up to 12 weeks
Trail Making Test
Time frame: Baseline time 0 and up to 12 weeks
Wechsler Adult Intelligence Scale
Time frame: Baseline time 0 and up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Smania, MD 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted gait training group+VR and GEO in people with Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Picelli, MD (+390458124573, aliessandro.picelli@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meters Walking test (10-MtWT) change in gait speed (m/sec) (time frame: Baseline time 0 and up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.