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

NCT ID: NCT04497545

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-24
• Study Completion Date: 2020-01-13

Brief Summary

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

Luna EMG

Intervention Type: DEVICE

The duration of the overall therapeutic intervention in both groups will be the same.

Control Group

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

Group Type: OTHER

lower limb rotor

Intervention Type: DEVICE

The duration of the overall therapeutic intervention in both groups will be the same.

Interventions

Luna EMG

The duration of the overall therapeutic intervention in both groups will be the same.

Intervention Type: DEVICE

lower limb rotor

The duration of the overall therapeutic intervention in both groups will be the same.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 91 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EGZOTech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rehstab

Limanowa, Malopolskie Voivodship, Poland

Countries

Poland

Other Identifiers

Limanowa Trial

Identifier Type: -

Identifier Source: org_study_id