LUNA-EMG to Enhance Motor Functions in Neurological Disorders

Sponsor

University of Liege (Other)

Overall Status

Recruiting

CT.gov ID

NCT04716829

Collaborator

Jean-François Kaux, MD PhD (Other), Jordan Roncin (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: LUNA-EMG	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

muscular strength in mV [12 weeks]
muscular strength will be measured with the EMG

Secondary Outcome Measures

Fugl-Meyer [12 weeks]
The scale evaluates motor capacities of the upper limb following a stroke. Scores range from 0 to 66 (the higher the better).
Modified Ashworth Scale [12 weeks]
This scale measures spasticity. The results are scored from 0 to 4 (the higher the more spastic).
Lovett [12 weeks]
This scale measures muscular strength. The scale ranges from 0 to 5 (the higher the better).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CNRF	Tinlot	Liege	Belgium	4557

Sponsors and Collaborators

University of Liege
Jean-François Kaux, MD PhD
Jordan Roncin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aurore Thibaut, PhD, University of Liege

ClinicalTrials.gov Identifier:

NCT04716829

Other Study ID Numbers:

2020-372

First Posted:

Jan 20, 2021

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aurore Thibaut, PhD, University of Liege

Additional relevant MeSH terms:

Nervous System Diseases

Study Results

No Results Posted as of May 18, 2022