Multiple Sclerosis RelapseNCT02834533
Role of Virtual Reality in MS Rehabilitation
A study testing Lokomat in people with Multiple Sclerosis Relapse, run by IRCCS Centro Neurolesi Bonino Pulejo.
Trial summary
Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS). Method: A Randomized, double-blind, controlled clinical trial was carried out in forty patients with relapsing remitting MS. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Multiple Sclerosis Relapse
- What is being tested?
- Lokomat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2015
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe walking disability with Expanded Disability Status Score (EDSS) between 3.5 and 6.0 (Pyramidal subitem ≥3)
- Montreal Cognitive Assessment score ≥24
- Absence of concomitant neurological or orthopedic conditions that may interfere with ambulation.
Who cannot join
- MS relapse during the three months prior to recruitment
- Not well defined pharmacological therapy; presence of paroxysmal vertigo
- Lower limb botulinum toxin injections within the previous 12 weeks
- Cardiorespiratory instability high-risk of spontaneous fracture
- Lower-limb skin lesions and phlebitis/thrombosis
- More than 130kg body weight
About this study
Official title: Robotic Gait Training in Multiple Sclerosis: a Randomized Clinical Trial Evaluating Virtual Reality Role
Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS).
Method: A Randomized, double-blind, controlled clinical trial was carried out in forty patients with relapsing remitting MS. All patients were randomized into two groups. One group practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded neurologist and psychologist administered clinical and neuropsychological scales. All the clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative program.
Read the detailed description
METHODS The present study is a single-blind randomized trial, conducted according to the Declaration of Helsinki, the guidelines for Good Clinical Practice, and the (CONSORT) Statement guidelines. The study protocol was approved by our Institutional Review Board and Ethics Committee (project number: 24/2013).
One hundred and fifty consecutive outpatients with relapsing-remitting multiple sclerosis and gait and/or balance disturbance, attending the Laboratory of Robotic Neurorehabilitation of the IRCCS Neurolesi Bonino-Pulejo (Messina, Italy) from January 2015 to January 2016, were invited to participate in the study, and were screened for study eligibility.
Inclusion/exclusion criteria Inclusion criteria were: age 30-65 years; severe walking disability with Expanded Disability Status Score between 3.5 and 6.0 (Piramidal subitem ≥3); Montreal Cognitive Assessment score ≥24; absence of concomitant neurological or orthopedic conditions that may interfere with ambulation; stable pharmacological therapy for at least 6 months. Exclusion criteria were: multiple sclerosis relapse during the three months prior to recruitment; presence of paroxysmal vertigo; lower limb botulinum toxin injections within the previous 12 weeks; cardiorespiratory instability; high-risk of spontaneous fracture; lower-limb skin lesions and phlebitis/thrombosis; more than 130 kg body weight.
Randomization Forty out of 150 outpatients with relapsing remitting multiple sclerosis form, according to Polman criteria14 selected between January 2015-2016, were enrolled and randomized and allocated into either Group1 (G1 i.e. Lokomat-Nanos) or Group2 (G2 i.e. Lokomat-Pro), as shown in fig 1. The subjects were randomly assigned to one of two treatment groups, using a simple randomization scheme generated by a software (www.randomization.com). Individual, sequentially numbered index cards with the random assignments were prepared. The index cards were folded and placed in sealed opaque envelopes. A physician member of the research team, who was blinded to the baseline examination findings, opened the envelopes to attribute the interventions according to the group assignments.
- Conditions
- Multiple Sclerosis Relapse
- Being tested
- Lokomat
- Keywords
- Lokomat;, robotic rehabilitation., Multiple Sclerosis;, Virtual reality
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LokomatDevice
Lokomat (Hocoma Inc., Zurich, Switzerland)includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . As compared to Lokomat-Nanos, the Pro device offers a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen.
| Study group | Role | What they receive |
|---|---|---|
| column heading in tables. | Active comparator | The group 1 (G1, n=20) underwent Lokomat-Nanos training. Each patient underwent 40 1h-training sessions (for 3 times a week). Both the study groups were treated by Lokomat (Hocoma Inc., Zurich, Switzerland), which includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . The overall duration of Lokomat therapy, including the time to get on and off, was 60min, while the robotic gait training lasted around 40min. Receives: Device: Lokomat |
| row and column in table | Active comparator | The group 2 (G2, n=20) underwent Lokomat-Pro training, with the same G1 sessions. The Pro device offers instead a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen. Receives: Device: Lokomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
BBS is a clinical scale to evaluate balance
Measured: Up to 14 weeks
Secondary outcomes (1)
Coping Orientation to Problem Experienced
The test is aimed at evaluating how a person deals with a specific problem, with two main coping strategies, i.e. adaptation and avoidance.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis RelapseStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Salvatore Calabrò, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834533
- Sponsor's protocol ID
- 24/2014
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We are planning this.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Gait Training in Multiple Sclerosis: a Randomized Clinical Trial Evaluating Virtual Reality Role
- ClinicalTrials.gov ID
- NCT02834533
- Acronym / sponsor ID
- 24/2014
- Conditions
- Multiple Sclerosis Relapse
- Keywords
- Lokomat;, robotic rehabilitation., Multiple Sclerosis;, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jul 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.
Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS).
Method: A Randomized, double-blind, controlled clinical trial was carried out in forty patients with relapsing remitting MS. All patients were randomized into two groups. One group practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded neurologist and psychologist administered clinical and neuropsychological scales. All the clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative program.
Detailed description
METHODS The present study is a single-blind randomized trial, conducted according to the Declaration of Helsinki, the guidelines for Good Clinical Practice, and the (CONSORT) Statement guidelines. The study protocol was approved by our Institutional Review Board and Ethics Committee (project number: 24/2013).
One hundred and fifty consecutive outpatients with relapsing-remitting multiple sclerosis and gait and/or balance disturbance, attending the Laboratory of Robotic Neurorehabilitation of the IRCCS Neurolesi Bonino-Pulejo (Messina, Italy) from January 2015 to January 2016, were invited to participate in the study, and were screened for study eligibility.
Inclusion/exclusion criteria Inclusion criteria were: age 30-65 years; severe walking disability with Expanded Disability Status Score between 3.5 and 6.0 (Piramidal subitem ≥3); Montreal Cognitive Assessment score ≥24; absence of concomitant neurological or orthopedic conditions that may interfere with ambulation; stable pharmacological therapy for at least 6 months. Exclusion criteria were: multiple sclerosis relapse during the three months prior to recruitment; presence of paroxysmal vertigo; lower limb botulinum toxin injections within the previous 12 weeks; cardiorespiratory instability; high-risk of spontaneous fracture; lower-limb skin lesions and phlebitis/thrombosis; more than 130 kg body weight.
Randomization Forty out of 150 outpatients with relapsing remitting multiple sclerosis form, according to Polman criteria14 selected between January 2015-2016, were enrolled and randomized and allocated into either Group1 (G1 i.e. Lokomat-Nanos) or Group2 (G2 i.e. Lokomat-Pro), as shown in fig 1. The subjects were randomly assigned to one of two treatment groups, using a simple randomization scheme generated by a software (www.randomization.com). Individual, sequentially numbered index cards with the random assignments were prepared. The index cards were folded and placed in sealed opaque envelopes. A physician member of the research team, who was blinded to the baseline examination findings, opened the envelopes to attribute the interventions according to the group assignments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| column heading in tables. | Active comparator | Device: LokomatThe group 1 (G1, n=20) underwent Lokomat-Nanos training. Each patient underwent 40 1h-training sessions (for 3 times a week). Both the study groups were treated by Lokomat (Hocoma Inc., Zurich, Switzerland), which includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . The overall duration of Lokomat therapy, including the time to get on and off, was 60min, while the robotic gait training lasted around 40min. |
| row and column in table | Active comparator | Device: LokomatThe group 2 (G2, n=20) underwent Lokomat-Pro training, with the same G1 sessions. The Pro device offers instead a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe walking disability with Expanded Disability Status Score (EDSS) between 3.5 and 6.0 (Pyramidal subitem ≥3)
- Montreal Cognitive Assessment score ≥24
- Absence of concomitant neurological or orthopedic conditions that may interfere with ambulation.
Key exclusion criteria (6 listed)
- MS relapse during the three months prior to recruitment
- Not well defined pharmacological therapy; presence of paroxysmal vertigo
- Lower limb botulinum toxin injections within the previous 12 weeks
- Cardiorespiratory instability high-risk of spontaneous fracture
- Lower-limb skin lesions and phlebitis/thrombosis
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 |
|---|---|---|
| LokomatLokomat (Hocoma Inc., Zurich, Switzerland)includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . As compared to Lokomat-Nanos, the Pro device offers a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen. | Device | column heading in tables., row and column in table |
Primary outcome
Berg Balance Scale
Time frame: Up to 14 weeks
BBS is a clinical scale to evaluate balance
1 secondary outcome
Coping Orientation to Problem Experienced
Time frame: Up to 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
- Individual participant dataSharing planned: Undecided. We are planning this.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat in people with Multiple Sclerosis Relapse, run by IRCCS Centro Neurolesi Bonino Pulejo.
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 3 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: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Up to 14 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 18 Jul 2016.