Multiple SclerosisRAMSESNCT03561155
Robot-assisted Arm Training in Multiple Sclerosis
A study testing Robot assisted treatment (Amadeo®) and Conventional treatment in people with Multiple Sclerosis and Rehabilitation, run by Universita di Verona at 1 site in Italy.
Trial summary
The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life. Effective arm-hand training programs are needed. Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Rehabilitation
- What is being tested?
- Robot assisted treatment (Amadeo®) and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to 1 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- EDSS score<8
- Mini Mental State Evaluation (MMSE) score>24
- Ashworth Scale Score<2 evaluated at the elbow, wrist and fingers
- Nine Hole Peg Test (NHPT) score >30 sec.
Who cannot join
- Disease recurrence that worsened significantly during the 3 months prior to recruitment
- Medical therapy not well defined
- Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program
- Severe visual dysfunction
- Performance of any type of rehabilitation treatment in the month prior to recruitment
- Other concomitant neurological or orthopaedic diseases involving the UL and interfering with their function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-intensity Robot-assisted Training in Hand Function Recovery and ADL Independence in Individuals With Multiple Sclerosis: a Randomized Controlled Single-blinded Trial
The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life. Effective arm-hand training programs are needed. Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke. Preliminary work in MS has focused on proximal sections of the arm. No study has evaluated the use of robotics for improving manual dexterity and their effects on cortical activity. The results of this research project could be relevant for the advancement of knowledge about UL functional recovery in individuals with MS and to determine the pattern of muscle activation underlying functional recovery.
Read the detailed description
Studies regarding the effectiveness of conventional and robot-based upper limb (UL) rehabilitation in individuals with MS is very limited.In the last 15 years, conventional rehabilitation of the UL in patients with neurological disorders has been enriched by the development of robots as they can provide high-intensity, repetitive, interactive and task-specific exercises.They are increasingly used in rehabilitation after stroke, therefore may also be good candidates for neuromotor rehabilitation of patients with MS. Furthermore, these devices can provide various feedbacks that can guide patients during the sensorimotor training and allow quantitative measurement of motor performance during training.One of these devices is the Amadeo®, a modern, mechatronic end-effector robotic device designed to improve sensorimotor functions in patients with restricted movement in individual fingers or in the entire hand.Another important issue concerns cortical plasticity, which plays a fundamental role in motor learning and neurorehabilitation.To date, the specific mechanisms leading to UL recovery after neurological rehabilitation are still unclear.The development of new EEG instruments allows brain activity to be tested under specific rehabilitation tasks contributes to give new insight in the dynamics of cortical networks reorganization promoted by rehabilitation.The main aim of the study is to perform a single blind RCT on 60 outpatients with MS (age:18-65 years;EDSS<8) in order to compare the efficacy of high-intensity robot-assisted training with conventional treatment on sensorimotor hand recovery, disability in ADLs and QoL.The secondary aim is to explore the underlying neuronal mechanisms of UL recovery by using EEG investigations and innovative robotic equipment. 10 controls (age 18-65 yrs) will undergo one session of the same Video-EEG acquisition to collect normative data to compare with data collected on patients.Each participant will receive 40-minute sessions over an 8 week period (3 days/week). Each session will consist of 30 minutes of hand training and 10 minutes of passive upper limbs mobilization.The experimental group will receive robot-assisted therapy by Amadeo.The control group will receive conventional rehabilitation.Before treatment, immediately after treatment, 1 month after treatment patients will be evaluated with a comprehensive protocol of all ICF domains as well as acquisition by Video-EEG acquisition combined with Amadeo® robotic training device.Primary outcome measures:Fugl-Meyer Assessment Motor Scale.Secondary measures: UL electromyographic analysis,Tremor Severity Scale, Nine Hole Peg Test, Amadeo® hand muscle strength (Newton), Motricity Index, Visual anolgue Scale for tiredness and fatigue; TEMPA, Motor Activity Log, Action Research Arm test, Multiple Sclerosis Quality of Life-54 and the assessment of Life Habits. Parametric tests and nonparametric tests will be performed according to variable distribution (p<.05)
- Conditions
- Multiple Sclerosis, Rehabilitation
- Being tested
- Robot assisted treatment (Amadeo®), Conventional treatment
- Keywords
- Upper Extremity, Recovery
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted treatment (Amadeo®)Device
Also called Robot assisted treatment
The protocol will consist of exercises as follows:
passive modality , passive/plus modality , assisted therapy and Balloon.
Conventional treatmentOther
The protocol will consist of exercises as follow:
upper limb mobilization, facilitation of movements and active tasks. The exercises will be focused on improving muscle strength, finger extension and flexion and motor control
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted treatment | Experimental | The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria). Receives: Device: Robot assisted treatment (Amadeo®) |
| Conventional treatment | Active comparator | The conventional group (CG) will undergo robot unassisted treatment (Conventional treatment). Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm test
Assesses upper limb functioning using observational methods
Measured: Up to 6 weeks
Secondary outcomes (10)
Fugl-Meyer Assessment Motor Scale - Arm Section
Evaluates and measures recovery in post-stroke hemiplegic patients
Measured: Up to 6 weeks
Motor Activity Log
Semi-structured interview to assess arm function.
Measured: Up to 6 weeks
Tremor Severity Scale
A clinical rating scale which measured the severity of tremor
Measured: Up to 6 weeks
Nine Hole Peg Test
Measures finger dexterity
Measured: Up to 6 weeks
Motricity Index
Measures of strength in upper limb
Measured: Up to 6 weeks
Amadeo® hand muscle strength (Newton)
Measures of muscle strenght using the robotic device
Measured: Up to 6 weeks
Visual anolgue Scale for tiredness and fatigue
Measures of tirediness and fatigue on a 10-point likert scale
Measured: Up to 6 weeks
Multiple Sclerosis Quality of Life-54
Measures of a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
Measured: Up to 6 weeks
Assessment of Life Habits
Assesses participants on 77 life habits from daily activities to social participation across 12 domains.
Measured: Up to 6 weeks
UL electromyographic analysis of muscle activation
Instrumental assessment of muscle activity during a reaching task
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study startNov 2014
- Primary completion1 Sep 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
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, Professor, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561155
- Sponsor's protocol ID
- FISM 14/14/F14
- Acronym
- RAMSES
- Status last verified
- Jun 2018
- First submitted
- 23 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gandolfi M, Vale N, Dimitrova EK, Mazzoleni S, Battini E, Benedetti MD, Gajofatto A, Ferraro F, Castelli M, Camin M, Filippetti M, De Paoli C, Chemello E, Picelli A, Corradi J, Waldner A, Saltuari L, Smania N. Effects of High-intensity Robot-assisted Hand Training on Upper Limb Recovery and Muscle Activity in Individuals With Multiple Sclerosis: A Randomized, Controlled, Single-Blinded Trial. Front Neurol. 2018 Oct 24;9:905. doi: 10.3389/fneur.2018.00905. eCollection 2018.
PubMed 30405526
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Robot-assisted Training in Hand Function Recovery and ADL Independence in Individuals With Multiple Sclerosis: a Randomized Controlled Single-blinded Trial
- ClinicalTrials.gov ID
- NCT03561155
- Acronym / sponsor ID
- RAMSES / FISM 14/14/F14
- Conditions
- Multiple Sclerosis, Rehabilitation
- Keywords
- Upper Extremity, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Jun 2018 (actual)
- 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.
The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life. Effective arm-hand training programs are needed. Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke. Preliminary work in MS has focused on proximal sections of the arm. No study has evaluated the use of robotics for improving manual dexterity and their effects on cortical activity. The results of this research project could be relevant for the advancement of knowledge about UL functional recovery in individuals with MS and to determine the pattern of muscle activation underlying functional recovery.
Detailed description
Studies regarding the effectiveness of conventional and robot-based upper limb (UL) rehabilitation in individuals with MS is very limited.In the last 15 years, conventional rehabilitation of the UL in patients with neurological disorders has been enriched by the development of robots as they can provide high-intensity, repetitive, interactive and task-specific exercises.They are increasingly used in rehabilitation after stroke, therefore may also be good candidates for neuromotor rehabilitation of patients with MS. Furthermore, these devices can provide various feedbacks that can guide patients during the sensorimotor training and allow quantitative measurement of motor performance during training.One of these devices is the Amadeo®, a modern, mechatronic end-effector robotic device designed to improve sensorimotor functions in patients with restricted movement in individual fingers or in the entire hand.Another important issue concerns cortical plasticity, which plays a fundamental role in motor learning and neurorehabilitation.To date, the specific mechanisms leading to UL recovery after neurological rehabilitation are still unclear.The development of new EEG instruments allows brain activity to be tested under specific rehabilitation tasks contributes to give new insight in the dynamics of cortical networks reorganization promoted by rehabilitation.The main aim of the study is to perform a single blind RCT on 60 outpatients with MS (age:18-65 years;EDSS<8) in order to compare the efficacy of high-intensity robot-assisted training with conventional treatment on sensorimotor hand recovery, disability in ADLs and QoL.The secondary aim is to explore the underlying neuronal mechanisms of UL recovery by using EEG investigations and innovative robotic equipment. 10 controls (age 18-65 yrs) will undergo one session of the same Video-EEG acquisition to collect normative data to compare with data collected on patients.Each participant will receive 40-minute sessions over an 8 week period (3 days/week). Each session will consist of 30 minutes of hand training and 10 minutes of passive upper limbs mobilization.The experimental group will receive robot-assisted therapy by Amadeo.The control group will receive conventional rehabilitation.Before treatment, immediately after treatment, 1 month after treatment patients will be evaluated with a comprehensive protocol of all ICF domains as well as acquisition by Video-EEG acquisition combined with Amadeo® robotic training device.Primary outcome measures:Fugl-Meyer Assessment Motor Scale.Secondary measures: UL electromyographic analysis,Tremor Severity Scale, Nine Hole Peg Test, Amadeo® hand muscle strength (Newton), Motricity Index, Visual anolgue Scale for tiredness and fatigue; TEMPA, Motor Activity Log, Action Research Arm test, Multiple Sclerosis Quality of Life-54 and the assessment of Life Habits. Parametric tests and nonparametric tests will be performed according to variable distribution (p<.05)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assisted treatment | Experimental | Device: Robot assisted treatment (Amadeo®)The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria). |
| Conventional treatment | Active comparator | Other: Conventional treatmentThe conventional group (CG) will undergo robot unassisted treatment (Conventional treatment). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-65 years
- EDSS score<8
- Mini Mental State Evaluation (MMSE) score>24
- Ashworth Scale Score<2 evaluated at the elbow, wrist and fingers
- Nine Hole Peg Test (NHPT) score >30 sec.
Key exclusion criteria (6 listed)
- Disease recurrence that worsened significantly during the 3 months prior to recruitment
- Medical therapy not well defined
- Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program
- Severe visual dysfunction
- Performance of any type of rehabilitation treatment in the month prior to recruitment
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 treatment (Amadeo®)Also: Robot assisted treatmentThe protocol will consist of exercises as follows: passive modality , passive/plus modality , assisted therapy and Balloon. | Device | Robot assisted treatment |
| Conventional treatmentThe protocol will consist of exercises as follow: upper limb mobilization, facilitation of movements and active tasks. The exercises will be focused on improving muscle strength, finger extension and flexion and motor control | Other | Conventional treatment |
Primary outcome
Action Research Arm test
Time frame: Up to 6 weeks
Assesses upper limb functioning using observational methods
10 secondary outcomes
Fugl-Meyer Assessment Motor Scale - Arm Section
Time frame: Up to 6 weeks
Motor Activity Log
Time frame: Up to 6 weeks
Tremor Severity Scale
Time frame: Up to 6 weeks
Nine Hole Peg Test
Time frame: Up to 6 weeks
Motricity Index
Time frame: Up to 6 weeks
Amadeo® hand muscle strength (Newton)
Time frame: Up to 6 weeks
Visual anolgue Scale for tiredness and fatigue
Time frame: Up to 6 weeks
Multiple Sclerosis Quality of Life-54
Time frame: Up to 6 weeks
Assessment of Life Habits
Time frame: Up to 6 weeks
UL electromyographic analysis of muscle activation
Time frame: Up to 6 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 19 Jun 2018.
- Derived from this study: PubMed 30405526Gandolfi M, Vale N, Dimitrova EK, Mazzoleni S, Battini E, Benedetti MD, Gajofatto A, Ferraro F, Castelli M, Camin M, Filippetti M, De Paoli C, Chemello E, Picelli A, Corradi J, Waldner A, Saltuari L, Smania N. Effects of High-intensity Robot-assisted Hand Training on Upper Limb Recovery and Muscle Activity in Individuals With Multiple Sclerosis: A Randomized, Controlled, Single-Blinded Trial. Front Neurol. 2018 Oct 24;9:905. doi: 10.3389/fneur.2018.00905. eCollection 2018.
- 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.
Nicola Smania, Professor principal investigator
Universita di Verona
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 treatment (Amadeo®) and Conventional treatment in people with Multiple Sclerosis and Rehabilitation, 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 5 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 19 Jun 2018. 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?
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?
Action Research Arm test (time frame: Up to 6 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 NCT03561155, which also lists 1 linked publication.
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 19 Jun 2018.