LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the lower limb in multiple sclerosis. This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG, 30-45 minutes once a week for 12 weeks) or in the control group (standard care). The effect of the training will be measured based on the muscular strength, walking tests, proprioception and a quality of life questionnaire.

Official Title
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LUNA-EMG to Enhance Lower Limb Motor Functions in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: LUNA-EMG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EDSS less or equal to 6.5 Between 18 and 70 years old Having signed the informed consent Exclusion Criteria: Acute pain syndrome Severe cognitive deficits Risk of fracture or unconsolidated fracture Rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints Severe ataxia and apraxia Epilepsy Pacemakers and similar implants Insufficient skin conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LUNA-EMG<br>The experimental group will receive 30 minutes of training with the LUNA-EMG once a week for 12 weeks. | Device: LUNA-EMG<br>* The LUNA-EMG (Samcom) system is a robot that allows the evaluation of muscular strength through the recording of muscle activity (electromyography - EMG) in order to provide precise objective data on the patient's muscle function. In addition to the diagnostic aspect (evaluation of muscle strength, range of motion and proprioception), the LUNA-EMG robot provides optimized range of motion's movements and a visual feedback on the patient's performance. In addition, it may enhance neuroplasticity due to the increased number of movements repetitions which could influence motor learning.<br>|
| No Intervention: Control<br>The control group will receive its rehabilitation care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength in mV | Muscular strength is measured with a dynamometer. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25-Foot Walk, seconds | The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The faster the better. | 12 weeks | 
| Timed Up and Go, seconds | The person must get up from the seated position and walk three meters away from the chair and then retrace their steps (turn 180 degrees) and sit down again. The faster the better. | 12 weeks | 
| Proprioception | Patients proprioception will be measured with the LUNA system. It calculates the distance in degree (°) between the target arm position and the arm position that the patient try to reproduce. Lower degree represent a more accurate positioning of the arm by the patient. | 12 weeks |