LUNA-EMG to Enhance Motor Functions in Neurological Disorders

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 upper limb in stroke This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG) or in the control group (standard care). The effect of the training will be measured with the EMG, the upper limb motor function and the quality of life.

Official Title
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Study of the Efficacy of the LUNA-EMG System on Motor Function in the Management of Neurological Disorders.

Conditions
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Stroke

Intervention / Treatment
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* Device: LUNA-EMG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 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

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 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 allows the adaptation of movements during rehabilitation sessions according to the individually generated strength.<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 |
| --- | --- | --- |
| muscular strength in mV | muscular strength will be measured with the EMG | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer | The scale evaluates motor capacities of the upper limb following a stroke. Scores range from 0 to 66 (the higher the better). | 12 weeks | 
| Modified Ashworth Scale | This scale measures spasticity. The results are scored from 0 to 4 (the higher the more spastic). | 12 weeks | 
| Lovett | This scale measures muscular strength. The scale ranges from 0 to 5 (the higher the better). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, EMG, rehabilitation, physiotherapy, occupational therapy