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

NCT04497545 | Completed

• 1 other identifier: Limanowa Trial
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Keywords

stroke,; rehabilitation,; EMG-triggered rehabilitation,; robotic-assisted movement,; gait

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

Luna EMG DEVICE

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

Study Group

lower limb rotor DEVICE

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

Control Group

Eligibility Criteria

• Age: 29 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EGZOTech: lead

Study Sites (1)

Rehstab

Limanowa, Malopolskie Voivodship, 34-600, Poland

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: February 24, 2019
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

PL (1)