LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Device: LUNA-EMG

• Registration Number: NCT04720898
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Study Start: 2021-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LUNA-EMG	LUNA-EMG	The experimental group will receive 30 minutes of training with the LUNA-EMG once a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Muscle strength in mV	12 weeks	Muscular strength is measured with a dynamometer.

Secondary Outcome Measures

Name	Time	Method
Timed Up and Go, seconds	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.
Timed 25-Foot Walk, seconds	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.
Proprioception	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.

Trial Locations

Locations (1)

CNRF; 🇧🇪 Tinlot, Liege, Belgium