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

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
LUNA-EMG
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CNRFRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LUNA-EMG

Control

Arm Description

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

The control group will receive its rehabilitation care.

Outcomes

Primary Outcome Measures

Muscle strength in mV
Muscular strength is measured with a dynamometer.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 19, 2021
Last Updated
May 9, 2023
Sponsor
University of Liege
Collaborators
Jean-François Kaux, MD PhD, Frank Houlmont
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1. Study Identification

Unique Protocol Identification Number
NCT04720898
Brief Title
LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis
Acronym
LUNA-MS
Official Title
LUNA-EMG to Enhance Lower Limb Motor Functions in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Jean-François Kaux, MD PhD, Frank Houlmont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LUNA-EMG
Arm Type
Experimental
Arm Description
The experimental group will receive 30 minutes of training with the LUNA-EMG once a week for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive its rehabilitation care.
Intervention Type
Device
Intervention Name(s)
LUNA-EMG
Intervention Description
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 Outcome Measure Information:
Title
Muscle strength in mV
Description
Muscular strength is measured with a dynamometer.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Timed 25-Foot Walk, seconds
Description
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.
Time Frame
12 weeks
Title
Timed Up and Go, seconds
Description
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.
Time Frame
12 weeks
Title
Proprioception
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurore Thibaut, PhD
Phone
+324843612
Email
athibaut@uliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Houlmont, MSc
Email
fhoulmont@chuliege.be
Facility Information:
Facility Name
CNRF
City
Tinlot
State/Province
Liege
ZIP/Postal Code
4557
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurore Thibaut, PhD
Email
athibaut@uliege.be
First Name & Middle Initial & Last Name & Degree
Frank Houlmont

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis

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