LUNA-EMG to Enhance Motor Functions in Neurological Disorders

Stroke Clinical Trial

— LUNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716829
• Other study ID #: 2020-372
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: University of Liege
• Contact: Aurore Thibaut
• Phone: +324843612
• Email: athibaut[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Belgium	CNRF	Tinlot	Liege

Sponsors (3)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscular strength in mV	muscular strength will be measured with the EMG	12 weeks
Secondary	Fugl-Meyer	The scale evaluates motor capacities of the upper limb following a stroke. Scores range from 0 to 66 (the higher the better).	12 weeks
Secondary	Modified Ashworth Scale	This scale measures spasticity. The results are scored from 0 to 4 (the higher the more spastic).	12 weeks
Secondary	Lovett	This scale measures muscular strength. The scale ranges from 0 to 5 (the higher the better).	12 weeks