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

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Luna EMG; Device: lower limb rotor

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Malopolskie Voivodship
    • Limanowa, Malopolskie Voivodship, Poland, 34-600
      • Rehstab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Luna EMG; The duration of the overall therapeutic intervention in both groups will be the same.
Other: Control Group; A four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor	Device: lower limb rotor; The duration of the overall therapeutic intervention in both groups will be the same.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Timed up and go test results	the test is performed from a sitting position. The patient on command is to get up from the chair to walk a distance of 3 meters, then turn back and sit on the chair	baseline, after 4 weeks, after 6 weeks
Change in Ashworth Scale results	Measurement of resistance during passive knee flexion and extension Scorse range from 0 to 4, with 5 choices: Grade 0: No increase in muscle tone. Grade 1: Slight increase in muscle tone, manifested by a catch and release or by minimal. resistance when the affected part is moved in flexion or extension. Grade 2: More marked increase in muscle tone, but affected part(s) easily moved. Grade 3: Considerable increase in muscle tone, passive movement difficult. Grade 4: Affected part(s) rigid in flexion or extension. Higher values represent a worse outcome.	baseline, after 4 weeks, after 6 weeks
Change in Rivermeade Motor Assessment (RMA)	The RMA assess functional mobility following stroke. Gross Function (RMA-Gf) : gait, balance, transfers. Each item is scored either yes "1" or no "0". It is based on Guttman scaling, which presumes that each subsequent item is of a more difficult nature. To advance to the next question, one must score (1) on an item, otherwise the test is stopped.	baseline, after 4 weeks, after 6 weeks
change in REPTY questionnair results	a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)	baseline, after 4 weeks, after 6 weeks
Change in Tight Circumference	thigh circumferences (5 and 15 centimeters above the patella),	baseline, after 4 weeks, after 6 weeks

Collaborators and Investigators

• Sponsor: EGZOTech

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2019
• Primary Completion (Actual): January 13, 2020
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 1, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: gait; stroke,; rehabilitation,; EMG-triggered rehabilitation,; robotic-assisted movement,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: Limanowa Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No