LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— LUNA-MS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720898
• Other study ID #: 2020-372b
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: University of Liege
• Contact: Aurore Thibaut, PhD
• Phone: +324843612
• Email: athibaut[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	CNRF	Tinlot	Liege

Sponsors (3)

Lead Sponsor	Collaborator
University of Liege	Frank Houlmont, Jean-François Kaux, MD PhD

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength in mV	Muscular strength is measured with a dynamometer.	12 weeks
Secondary	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
Secondary	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
Secondary	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