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Robot-assisted Arm Training in Multiple Sclerosis (RAMSES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561155
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nicola Smania, MD, Clinical Professor, Universita di Verona

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Rehabilitation Device: Robot assisted treatment (Amadeo®) Other: Conventional treatment Not Applicable

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)

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot assisted treatment
The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria).
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).
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





Primary Outcome Measures :
  1. Action Research Arm test [ Time Frame: Up to 6 weeks ]
    Assesses upper limb functioning using observational methods


Secondary Outcome Measures :
  1. Fugl-Meyer Assessment Motor Scale - Arm Section [ Time Frame: Up to 6 weeks ]
    Evaluates and measures recovery in post-stroke hemiplegic patients

  2. Motor Activity Log [ Time Frame: Up to 6 weeks ]
    Semi-structured interview to assess arm function.

  3. Tremor Severity Scale [ Time Frame: Up to 6 weeks ]
    A clinical rating scale which measured the severity of tremor

  4. Nine Hole Peg Test [ Time Frame: Up to 6 weeks ]
    Measures finger dexterity

  5. Motricity Index [ Time Frame: Up to 6 weeks ]
    Measures of strength in upper limb

  6. Amadeo® hand muscle strength (Newton) [ Time Frame: Up to 6 weeks ]
    Measures of muscle strenght using the robotic device

  7. Visual anolgue Scale for tiredness and fatigue [ Time Frame: Up to 6 weeks ]
    Measures of tirediness and fatigue on a 10-point likert scale

  8. 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.

  9. 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.

  10. UL electromyographic analysis of muscle activation [ Time Frame: Up to 6 weeks ]
    Instrumental assessment of muscle activity during a reaching task



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
UOC Neurorehabilitation
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Investigators
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Principal Investigator: Nicola Smania, Professor Universita di Verona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Nicola Smania, MD, Clinical Professor, Universita di Verona:
Upper Extremity
Recovery
Additional relevant MeSH terms:
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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