NCT04497545

The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients

Completed NA Last updated 4 August 2020

What this trial tests

NA trial testing Luna EMG in Ischemic Stroke in 71 participants. Completed in 13 January 2020.

Timeline

24 February 2019

Primary endpoint
13 January 2020

13 January 2020

Quick facts

Lead sponsor	EGZOTech
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	24 February 2019
Primary completion	13 January 2020
Estimated completion	13 January 2020
Sites	1 location across Poland

Drugs / interventions tested

• Luna EMG
• lower limb rotor

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

EGZOTech

Who can join

Adults 29 to 91, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. Objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. Each patient was randomly assigned to an intervention (robot) or control group (RG or CG). All patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for 6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG received exercises on the lower limb rotor. Patients were evaluated before the start of the study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle circumference on the thigh.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Influence of EMG-Triggered Robotic Movement on Walking, Muscle Force and Spasticity after an Ischemic Stroke.
   Lewandowska-Sroka P, Stabrawa R, Kozak D, Poświata A, et al · · 2021 · cited 4× · PMID 33801295 · DOI 10.3390/medicina57030227