Multiple SclerosisMS-ROBOTNCT02711566
Robot-based Rehabilitation of Upper Limb Impairment in Multiple Sclerosis
A study testing Physioassistant: Haptic training and Physioassistant: Sensorimotor training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke survivors. Robots can be programmed to interact with patients by guiding their movements, by monitoring their performance and by quantifying the type and degree of their impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physioassistant: Haptic training and Physioassistant: Sensorimotor training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- definite Multiple sclerosis, stable phase of the disease
- no relapses or worsening >1 in the Expanded Disability Status Scale in the last three months,
- Expanded Disability Status Scale<7.5,
- Ashworth score at the upper limb lower than 2,
- Nine-Hole Peg Test between 30 s and 180 s
Who cannot join
- previous treatment with robot therapy,
- presence of severe nystagmus,
- visual acuity less than 4/10
- major orthopaedic or other disorders interfering with the protocol
About this study
Official title: Robot-based Assessment and Therapy in the Treatment of Upper Limb Impairment in Multiple Sclerosis: a Multi-center, Randomised Controlled Trial
Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke survivors. Robots can be programmed to interact with patients by guiding their movements, by monitoring their performance and by quantifying the type and degree of their impairment.
A distinctive element of multiple sclerosis is the involvement of a variety of functional systems, in a way that is highly subject-specific. This requires a personalization of treatment, and continuous adaptation to changes in condition. This points to a need for integrating patient assessment, definition of rehabilitation protocols, their administration and the assessment of their outcome.
The goal of this study is to assess, in persons with MS, the efficacy of a type of robot-assisted training that was specifically designed to counteract incoordination and muscle weakness (typical of MS), tailored to individual type and degree of impairment, when compared to simple movement training.
Read the detailed description
In recent years, the potential of robots in the treatment of persons with motor disabilities has raised considerable interest. These devices may interact with patients by assisting or perturbing their movements, may monitor their performance and even quantify their impairment. Clinical trials involving stroke survivors clearly demonstrated that robot-therapy results in improved motor control. More recently, robot-therapy has been applied to other pathologies. A pilot study carried out by the proponents suggested that Multiple Sclerosis (MS) subjects with predominantly cerebellar symptoms may indeed benefit from robot-therapy. MS subjects with different symptoms may benefit from robot therapy as well, but the variety of symptoms and degrees of impairment that is typical of MS suggests that robots may fully show their potential if therapy is tailored on the individual subjects.
In this study, the proponents aim at extending the results of the above mentioned pilot study to MS subjects with a wider variety of impairments. Based on previous studies on robot therapy with MS subjects and stroke survivors, the proponents will develop and test a robot training exercise that is specifically designed to deal with incoordination and/or muscle weakness. In a randomised controlled trial, the proponents will then assess the possible contribution of this form of robot-therapy to the rehabilitation of MS subjects.
A population of clinically definite MS subjects with different degrees of upper limb impairment was randomised into 2 groups: (i) Haptic training and (ii) Sensorimotor training.
Haptic training was based on a robot-assisted exercise protocol specifically designed to treat cerebellar and motor symptoms in persons with MS by counteracting, respectively, incoordination and muscle weakness. The exercise is based on a motor task - interaction with a virtual mass-spring system under the effect of a resistive load - that requires sophisticated coordination skills. Task difficulty (the time constant of the mass-spring system) and the magnitude of the resistive load (stiffness magnitude of the resistive spring) were automatically adjusted to the individual subjects' upper limb impairment.
In Sensorimotor training, the task is exactly the same, but the robot generates no forces. Hand and target position are displayed on the computer screen. This group allowed quantifying the specific contribution of robot assistance to sensorimotor recovery (if any). Both groups performed 8-10 therapy sessions (1 hour/each, 2-3 times per week). Treatment outcome was assessed in terms of the Nine-Hole Peg Test (9HPT) and the ARAT scores.
- Conditions
- Multiple Sclerosis
- Being tested
- Physioassistant: Haptic training, Physioassistant: Sensorimotor training
- Keywords
- Rehabilitation, Robot-assisted therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physioassistant: Haptic trainingDevice
Subjects in the Haptic training arm had to perform fast-and-accurate reaching movements in different directions. reaching was mediated by a virtual 'tool', consisting of a virtual point mass (m=5 kg) connected to the subjects' hand through a linear spring (stiffness range: Km=200-500 N/m). An additional spring (stiffness range: Kr = 20-70 N/m) was connected between hand a starting point to resist movements. Subjects were instructed to move the virtual point mass as fast as possible through suitable hand motions, so that the mass ends up and stops on the 'target' area.
Physioassistant: Sensorimotor trainingDevice
Subjects in the Sensorimotor training arm had to perform fast-and-accurate reaching movements in different directions. The manipulandum was only used to record hand movements, but throughout the movement it generated no forces.
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor training | Active comparator | Patients in this arm were assigned to the 'Physioassistant: Haptic training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation.
All participating centers used the exact same apparatus and experimental set-up. Receives: Device: Physioassistant: Sensorimotor training |
| Haptic training | Experimental | Patients in this arm were assigned to the 'Physioassistant: Sensorimotor training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up. Receives: Device: Physioassistant: Haptic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the 9 Hole Peg Test score
Measured: baseline and 4 weeks and baseline and 16 weeks
Secondary outcomes (3)
Treatment change in percentage of responders at 9 Hole Peg Test score
Number of responders i.e. the subjects who experienced an improvement greater than 20% at the 9HPT
Measured: baseline and 4 weeks and baseline and 16 weeks
Absolute change of exercise performance
Performance score (a combination of a movement duration and a path length component, with equal weights)
Measured: baseline and 4 weeks and baseline and 16 weeks
Absolute change of task difficulty
Resistive and mass-spring stiffness (Haptic group only)
Measured: baseline and 4 weeks and baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova, Azienda Sanitaria Locale 3 Genovese
- Responsible party
- Sponsor
- Investigators
- Claudio M Solaro, MD, Principal investigator, ASL 3 Genovese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711566
- Sponsor's protocol ID
- FISM_Robot
- Acronym
- MS-ROBOT
- Status last verified
- May 2015
- First submitted
- 29 Feb 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Basteris A, De Luca A, Sanguineti V, Solaro C, Mueller M, Carpinella I, Cattaneo D, Bertoni R, Ferrarin M. A tailored exercise of manipulation of virtual tools to treat upper limb impairment in Multiple Sclerosis. IEEE Int Conf Rehabil Robot. 2011;2011:5975509. doi: 10.1109/ICORR.2011.5975509.
PubMed 22275705Solaro C, Cattaneo D, Basteris A, Carpinella I, De Luca A, Mueller M, Bertoni R, Ferrarin M, Sanguineti V. Haptic vs sensorimotor training in the treatment of upper limb dysfunction in multiple sclerosis: A multi-center, randomised controlled trial. J Neurol Sci. 2020 May 15;412:116743. doi: 10.1016/j.jns.2020.116743. Epub 2020 Feb 19.
PubMed 32145522
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-based Assessment and Therapy in the Treatment of Upper Limb Impairment in Multiple Sclerosis: a Multi-center, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02711566
- Acronym / sponsor ID
- MS-ROBOT / FISM_Robot
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Robot-assisted therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Genova, Azienda Sanitaria Locale 3 Genovese
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Mar 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.
Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke survivors. Robots can be programmed to interact with patients by guiding their movements, by monitoring their performance and by quantifying the type and degree of their impairment.
A distinctive element of multiple sclerosis is the involvement of a variety of functional systems, in a way that is highly subject-specific. This requires a personalization of treatment, and continuous adaptation to changes in condition. This points to a need for integrating patient assessment, definition of rehabilitation protocols, their administration and the assessment of their outcome.
The goal of this study is to assess, in persons with MS, the efficacy of a type of robot-assisted training that was specifically designed to counteract incoordination and muscle weakness (typical of MS), tailored to individual type and degree of impairment, when compared to simple movement training.
Detailed description
In recent years, the potential of robots in the treatment of persons with motor disabilities has raised considerable interest. These devices may interact with patients by assisting or perturbing their movements, may monitor their performance and even quantify their impairment. Clinical trials involving stroke survivors clearly demonstrated that robot-therapy results in improved motor control. More recently, robot-therapy has been applied to other pathologies. A pilot study carried out by the proponents suggested that Multiple Sclerosis (MS) subjects with predominantly cerebellar symptoms may indeed benefit from robot-therapy. MS subjects with different symptoms may benefit from robot therapy as well, but the variety of symptoms and degrees of impairment that is typical of MS suggests that robots may fully show their potential if therapy is tailored on the individual subjects.
In this study, the proponents aim at extending the results of the above mentioned pilot study to MS subjects with a wider variety of impairments. Based on previous studies on robot therapy with MS subjects and stroke survivors, the proponents will develop and test a robot training exercise that is specifically designed to deal with incoordination and/or muscle weakness. In a randomised controlled trial, the proponents will then assess the possible contribution of this form of robot-therapy to the rehabilitation of MS subjects.
A population of clinically definite MS subjects with different degrees of upper limb impairment was randomised into 2 groups: (i) Haptic training and (ii) Sensorimotor training.
Haptic training was based on a robot-assisted exercise protocol specifically designed to treat cerebellar and motor symptoms in persons with MS by counteracting, respectively, incoordination and muscle weakness. The exercise is based on a motor task - interaction with a virtual mass-spring system under the effect of a resistive load - that requires sophisticated coordination skills. Task difficulty (the time constant of the mass-spring system) and the magnitude of the resistive load (stiffness magnitude of the resistive spring) were automatically adjusted to the individual subjects' upper limb impairment.
In Sensorimotor training, the task is exactly the same, but the robot generates no forces. Hand and target position are displayed on the computer screen. This group allowed quantifying the specific contribution of robot assistance to sensorimotor recovery (if any). Both groups performed 8-10 therapy sessions (1 hour/each, 2-3 times per week). Treatment outcome was assessed in terms of the Nine-Hole Peg Test (9HPT) and the ARAT scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor training | Active comparator | Device: Physioassistant: Sensorimotor trainingPatients in this arm were assigned to the 'Physioassistant: Haptic training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up. |
| Haptic training | Experimental | Device: Physioassistant: Haptic trainingPatients in this arm were assigned to the 'Physioassistant: Sensorimotor training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- definite Multiple sclerosis, stable phase of the disease
- no relapses or worsening >1 in the Expanded Disability Status Scale in the last three months,
- Expanded Disability Status Scale<7.5,
- Ashworth score at the upper limb lower than 2,
- Nine-Hole Peg Test between 30 s and 180 s
Key exclusion criteria (4 listed)
- previous treatment with robot therapy,
- presence of severe nystagmus,
- visual acuity less than 4/10
- major orthopaedic or other disorders interfering with the protocol
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 |
|---|---|---|
| Physioassistant: Haptic trainingSubjects in the Haptic training arm had to perform fast-and-accurate reaching movements in different directions. reaching was mediated by a virtual 'tool', consisting of a virtual point mass (m=5 kg) connected to the subjects' hand through a linear spring (stiffness range: Km=200-500 N/m). An additional spring (stiffness range: Kr = 20-70 N/m) was connected between hand a starting point to resist movements. Subjects were instructed to move the virtual point mass as fast as possible through suitable hand motions, so that the mass ends up and stops on the 'target' area. | Device | Haptic training |
| Physioassistant: Sensorimotor trainingSubjects in the Sensorimotor training arm had to perform fast-and-accurate reaching movements in different directions. The manipulandum was only used to record hand movements, but throughout the movement it generated no forces. | Device | Sensorimotor training |
Primary outcome
Change of the 9 Hole Peg Test score
Time frame: baseline and 4 weeks and baseline and 16 weeks
3 secondary outcomes
Treatment change in percentage of responders at 9 Hole Peg Test score
Time frame: baseline and 4 weeks and baseline and 16 weeks
Absolute change of exercise performance
Time frame: baseline and 4 weeks and baseline and 16 weeks
Absolute change of task difficulty
Time frame: baseline and 4 weeks and baseline and 16 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 17 Mar 2016.
- Background: PubMed 22275705Basteris A, De Luca A, Sanguineti V, Solaro C, Mueller M, Carpinella I, Cattaneo D, Bertoni R, Ferrarin M. A tailored exercise of manipulation of virtual tools to treat upper limb impairment in Multiple Sclerosis. IEEE Int Conf Rehabil Robot. 2011;2011:5975509. doi: 10.1109/ICORR.2011.5975509.
- Derived from this study: PubMed 32145522Solaro C, Cattaneo D, Basteris A, Carpinella I, De Luca A, Mueller M, Bertoni R, Ferrarin M, Sanguineti V. Haptic vs sensorimotor training in the treatment of upper limb dysfunction in multiple sclerosis: A multi-center, randomised controlled trial. J Neurol Sci. 2020 May 15;412:116743. doi: 10.1016/j.jns.2020.116743. Epub 2020 Feb 19.
- Individual participant dataSharing planned: Undecided
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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.
Claudio M Solaro, MD principal investigator
ASL 3 Genovese
Questions about this trial
What is this clinical trial studying?
A study testing Physioassistant: Haptic training and Physioassistant: Sensorimotor training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS.
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 5 inclusion and 4 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 17 Mar 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?
Change of the 9 Hole Peg Test score (time frame: baseline and 4 weeks and baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711566, which also lists 2 linked publications.
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 17 Mar 2016.