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Completed

NCT Number: NCT04497545

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

29 year–91 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehstab

Limanowa, Malopolskie Voivodship, 34-600, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Luna EMG

Device

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

lower limb rotor

Device

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

Primary outcomes

  1. Change in Timed up and go test results

    Time frame: baseline, after 4 weeks, after 6 weeks

    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

  2. Change in Ashworth Scale results

    Time frame: baseline, after 4 weeks, after 6 weeks

    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.

  3. Change in Rivermeade Motor Assessment (RMA)

    Time frame: baseline, after 4 weeks, after 6 weeks

    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.

  4. change in REPTY questionnair results

    Time frame: baseline, after 4 weeks, after 6 weeks

    a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)

  5. Change in Tight Circumference

    Time frame: baseline, after 4 weeks, after 6 weeks

    thigh circumferences (5 and 15 centimeters above the patella),

Sponsors and collaborators

Lead sponsor

EGZOTech

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2020
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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