Robot-assisted Arm Training in Multiple Sclerosis
Condition: Multiple Sclerosis; Rehabilitation
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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)
    

Intervention name(s): Robot assisted treatment (Amadeo®); Conventional treatment
Intervention type(s): Device; Other
Intervention description(s): The protocol will consist of exercises as follows:
passive modality , passive/plus modality , assisted therapy and Balloon.; 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
Other intervention name(s): Robot assisted treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upper Extremity; Recovery