LUNA-EMG to Enhance Motor Functions in Neurological Disorders (LUNA)

July 30, 2025 updated by: Aurore Thibaut, University of Liege

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Liege
      • Tinlot, Liege, Belgium, 4557
        • CNRF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LUNA-EMG
The experimental group will receive 30 minutes of training with the LUNA-EMG 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 allows the adaptation of movements during rehabilitation sessions according to the individually generated strength.
No Intervention: Control
The control group will receive its rehabilitation care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscular strength in mV
Time Frame: 12 weeks
muscular strength will be measured with the EMG
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer
Time Frame: 12 weeks
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
Time Frame: 12 weeks
This scale measures spasticity. The results are scored from 0 to 4 (the higher the more spastic).
12 weeks
Lovett
Time Frame: 12 weeks
This scale measures muscular strength. The scale ranges from 0 to 5 (the higher the better).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Collaborators

CHU Liège - Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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