Clinical trial NCT03561155: Robot-assisted Arm Training in Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Rehabilitation
Keywords: Upper Extremity
Recovery
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Action Research Arm test
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment Motor Scale - Arm Section
timeFrame: Up to 6 weeks
measure: Motor Activity Log
timeFrame: Up to 6 weeks
measure: Tremor Severity Scale
timeFrame: Up to 6 weeks
measure: Nine Hole Peg Test
timeFrame: Up to 6 weeks
measure: Motricity Index
timeFrame: Up to 6 weeks
measure: Amadeo® hand muscle strength (Newton)
timeFrame: Up to 6 weeks
measure: Visual anolgue Scale for tiredness and fatigue
timeFrame: Up to 6 weeks
measure: Multiple Sclerosis Quality of Life-54
timeFrame: Up to 6 weeks
measure: Assessment of Life Habits
timeFrame: Up to 6 weeks
measure: UL electromyographic analysis of muscle activation
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: UOC Neurorehabilitation
Study officials:
affiliation: Universita di Verona
name: Nicola Smania, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.