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

EGZOTech

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: Luna EMG; Device: lower limb rotor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04497545

Limanowa Trial

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 29 to 91 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ischemic stroke,
• not later than 6 months ago,
• muscle strength of extensors and knee flexors on the Lovetta scale below 3,
• functional disorders of the lower limb,
• patient's condition allowing full understanding of commands
• continued/uninterrupted rehabilitation process for 28 days

Exclusion criteria

• cognitive impairment-lack of or poor cooperation between the patient and the therapist,
• stroke (more than 6 months after the incident),
• unstable clinical condition,
• muscle strength of knee extensors and flexors on the Lovett scale greater than or equal to 3,
• rigid fixed contractures within the lower limb,
• significant spasticity (Ashworth scale of 3 and above)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Study Group

Experimental group

Description:

A four-week rehabilitation program (Monday to Friday) involving the hour of individual therapy and 30 minutes of therapy on the Luna EMG device.

Treatment:

Device: Luna EMG

Control Group

Other group

Description:

A four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor

Treatment:

Device: lower limb rotor