Robot-assisted Arm Training in Multiple Sclerosis (RAMSES)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Rehabilitation
• Intervention / Treatment: Device: Robot assisted treatment (Amadeo®); Other: Conventional treatment

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • UOC Neurorehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm test	Assesses upper limb functioning using observational methods	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment Motor Scale - Arm Section	Evaluates and measures recovery in post-stroke hemiplegic patients	Up to 6 weeks
Motor Activity Log	Semi-structured interview to assess arm function.	Up to 6 weeks
Tremor Severity Scale	A clinical rating scale which measured the severity of tremor	Up to 6 weeks
Nine Hole Peg Test	Measures finger dexterity	Up to 6 weeks
Motricity Index	Measures of strength in upper limb	Up to 6 weeks
Amadeo® hand muscle strength (Newton)	Measures of muscle strenght using the robotic device	Up to 6 weeks
Visual anolgue Scale for tiredness and fatigue	Measures of tirediness and fatigue on a 10-point likert scale	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.	Up to 6 weeks
Assessment of Life Habits	Assesses participants on 77 life habits from daily activities to social participation across 12 domains.	Up to 6 weeks
UL electromyographic analysis of muscle activation	Instrumental assessment of muscle activity during a reaching task	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Nicola Smania, Professor, Universita di Verona

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Recovery; Upper Extremity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: FISM 14/14/F14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED