LUNA-EMG to Enhance Motor Functions in Neurological Disorders

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT04716829
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-20
• 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: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
muscular strength in mV	12 weeks	muscular strength will be measured with the EMG

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

CNRF; 🇧🇪 Tinlot, Liege, Belgium