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Completed

NCT Number: NCT04720898

LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CNRF

Tinlot, Liege, 4557, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LUNA-EMG

Device

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.

Primary outcomes

  1. Muscle strength in mV

    Time frame: 12 weeks

    Muscular strength is measured with a dynamometer.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Acronym: LUNA-MS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2021
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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