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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
Sponsor:
Information provided by (Responsible Party):
Nicola Smania, MD, Clinical Professor, Universita di Verona

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date June 19, 2018
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
Action Research Arm test [ Time Frame: Up to 6 weeks ]
Assesses upper limb functioning using observational methods
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robot-assisted Arm Training in Multiple Sclerosis
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Rehabilitation
Intervention  ICMJE
  • 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
  • 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

Study Arms  ICMJE
  • Experimental: Robot assisted treatment
    The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria).
    Intervention: Device: Robot assisted treatment (Amadeo®)
  • Active Comparator: Conventional treatment
    The conventional group (CG) will undergo robot unassisted treatment (Conventional treatment).
    Intervention: Other: Conventional treatment
Publications * Gandolfi M, Valè 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2018)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03561155
Other Study ID Numbers  ICMJE FISM 14/14/F14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nicola Smania, MD, Clinical Professor, Universita di Verona
Study Sponsor  ICMJE Universita di Verona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicola Smania, Professor Universita di Verona
PRS Account Universita di Verona
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP