Robot-assisted Arm Training in Multiple Sclerosis (RAMSES)
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ClinicalTrials.gov Identifier: NCT03561155 |
Recruitment Status :
Completed
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
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Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis Rehabilitation | Device: Robot assisted treatment (Amadeo®) Other: Conventional treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 2014 |
Actual Primary Completion Date : | September 1, 2017 |
Actual Study Completion Date : | May 1, 2018 |

Arm | Intervention/treatment |
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Experimental: Robot assisted treatment
The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria).
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Device: Robot assisted treatment (Amadeo®)
The protocol will consist of exercises as follows: passive modality , passive/plus modality , assisted therapy and Balloon. Other Name: Robot assisted treatment |
Active Comparator: Conventional treatment
The conventional group (CG) will undergo robot unassisted treatment (Conventional treatment).
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Other: Conventional treatment
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 |
- Action Research Arm test [ Time Frame: Up to 6 weeks ]Assesses upper limb functioning using observational methods
- Fugl-Meyer Assessment Motor Scale - Arm Section [ Time Frame: Up to 6 weeks ]Evaluates and measures recovery in post-stroke hemiplegic patients
- Motor Activity Log [ Time Frame: Up to 6 weeks ]Semi-structured interview to assess arm function.
- Tremor Severity Scale [ Time Frame: Up to 6 weeks ]A clinical rating scale which measured the severity of tremor
- Nine Hole Peg Test [ Time Frame: Up to 6 weeks ]Measures finger dexterity
- Motricity Index [ Time Frame: Up to 6 weeks ]Measures of strength in upper limb
- Amadeo® hand muscle strength (Newton) [ Time Frame: Up to 6 weeks ]Measures of muscle strenght using the robotic device
- Visual anolgue Scale for tiredness and fatigue [ Time Frame: Up to 6 weeks ]Measures of tirediness and fatigue on a 10-point likert scale
- Multiple Sclerosis Quality of Life-54 [ Time Frame: Up to 6 weeks ]Measures of a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
- Assessment of Life Habits [ Time Frame: Up to 6 weeks ]Assesses participants on 77 life habits from daily activities to social participation across 12 domains.
- UL electromyographic analysis of muscle activation [ Time Frame: Up to 6 weeks ]Instrumental assessment of muscle activity during a reaching task

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561155
Italy | |
UOC Neurorehabilitation | |
Verona, Italy, 37134 |
Principal Investigator: | Nicola Smania, Professor | Universita di Verona |
Responsible Party: | Nicola Smania, MD, Clinical Professor, Professor, Universita di Verona |
ClinicalTrials.gov Identifier: | NCT03561155 |
Other Study ID Numbers: |
FISM 14/14/F14 |
First Posted: | June 19, 2018 Key Record Dates |
Last Update Posted: | June 19, 2018 |
Last Verified: | June 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Upper Extremity Recovery |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |