Robot-assisted Arm Training in Multiple Sclerosis

NCT ID: NCT03561155

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-05-01

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)

Conditions

Multiple Sclerosis; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robot assisted treatment

The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria).

Group Type: EXPERIMENTAL

Robot assisted treatment (Amadeo®)

Intervention Type: DEVICE

The protocol will consist of exercises as follows:

passive modality , passive/plus modality , assisted therapy and Balloon.

Conventional treatment

The conventional group (CG) will undergo robot unassisted treatment (Conventional treatment).

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

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

Interventions

Robot assisted treatment (Amadeo®)

The protocol will consist of exercises as follows:

passive modality , passive/plus modality , assisted therapy and Balloon.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Other Intervention Names

Robot assisted treatment

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Nicola Smania, MD, Clinical Professor

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Smania, Professor

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

UOC Neurorehabilitation

Verona, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 30405526 (View on PubMed)

Other Identifiers

FISM 14/14/F14

Identifier Type: -

Identifier Source: org_study_id