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LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis (LUNA-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04720898
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : August 12, 2021
Sponsor:
Collaborators:
Jean-François Kaux, MD PhD
Frank Houlmont
Information provided by (Responsible Party):
Aurore Thibaut, University of Liege

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: LUNA-EMG Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LUNA-EMG to Enhance Lower Limb Motor Functions in Multiple Sclerosis
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LUNA-EMG
The experimental group will receive 30 minutes of training with the LUNA-EMG once a week for 12 weeks.
 Device: LUNA-EMG
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.
No Intervention: Control
The control group will receive its rehabilitation care.


Outcome Measures
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Primary Outcome Measures :
  1. Muscle strength in mV [ Time Frame: 12 weeks ]
    Muscular strength is measured with a dynamometer.


Secondary Outcome Measures :
  1. Timed 25-Foot Walk, seconds [ Time Frame: 12 weeks ]
    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.

  2. Timed Up and Go, seconds [ Time Frame: 12 weeks ]
    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.

  3. Proprioception [ Time Frame: 12 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720898


Contacts
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Contact: Aurore Thibaut, PhD +324843612 athibaut@uliege.be
Contact: Frank Houlmont, MSc fhoulmont@chuliege.be

Locations
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Belgium
CNRF Recruiting
Tinlot, Liege, Belgium, 4557
Contact: Aurore Thibaut, PhD       athibaut@uliege.be   
Principal Investigator: Frank Houlmont         
Sponsors and Collaborators
University of Liege
Jean-François Kaux, MD PhD
Frank Houlmont
More Information
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Responsible Party: Aurore Thibaut, PhD, University of Liege
ClinicalTrials.gov Identifier: NCT04720898    
Other Study ID Numbers: 2020-372b
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases