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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497545
• Other study ID #: Limanowa Trial
• Status: Completed
• Phase: N/A
• Start date: February 24, 2019
• Est. completion date: January 13, 2020

Study information

• Verified date: July 2020
• Source: EGZOTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 91 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• Luna EMG
The duration of the overall therapeutic intervention in both groups will be the same.
• lower limb rotor
The duration of the overall therapeutic intervention in both groups will be the same.

Locations

Country	Name	City	State
Poland	Rehstab	Limanowa	Malopolskie Voivodship

Sponsors (1)

Lead Sponsor	Collaborator
EGZOTech

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Tight Circumference	thigh circumferences (5 and 15 centimeters above the patella),	baseline, after 4 weeks, after 6 weeks