Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03888118
Recruitment Status : Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Marzena Adamczyk, Rehamed Center

Brief Summary:
A lot of studies prove that rehabilitation with the use of modern devices accelerates the recovery of function in patients after stroke. Repeated correct movement patterns affect the central nervous system and stimulating its plasticity. Despite the fact that so many studies confirm the validity of therapy using robots, it is still difficult to assess to what extent its use improves the effectiveness of traditional therapy. In these studies, we want to objectively assess the effectiveness of the Luna device using EMG biofeedback.

Condition or disease Intervention/treatment Phase
Stroke Device: Luna EMG Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: Study Group
A four-week rehabilitation program (Monday to Friday) involving the hour of individual ankle therapy and one hour therapy on the Luna EMG device.
Device: Luna EMG
The duration of the overall therapeutic intervention in both groups will be the same.

No Intervention: Control group
A four-week rehabilitation program (Monday to Friday) involving two hours of individual ankle therapy.



Primary Outcome Measures :
  1. EMG using the Luna EMG [ Time Frame: 3 minutes ]
    EMG will be performed using the Luna EMG device also allowing the treatment and diagnosis. With Luna EMG we can supply objective, data driven diagnosis. Innervation diagnosis and motor unit recruitment through surface electromyography. We'd like to assess bioelectrical activity at the tibialis anterior muscle during relaxing for two minutes (mean, minimum and maximum electrical activity in muscle - in microvolts).

  2. EMG using the Luna EMG [ Time Frame: 1 minute ]
    EMG will be performed using the Luna EMG device also allowing the treatment and diagnosis. With Luna EMG we can supply objective, data driven diagnosis. Innervation diagnosis and motor unit recruitment through surface electromyography. We'd like to assess bioelectrical activity at the tibialis anterior muscle activation patterns during three times dorsiflexion (mean, minimum and maximum electrical activity in muscle - in microvolts).

  3. Lovett scale [ Time Frame: 1 minute ]

    The muscle strength in Lovett scale is graded on a scale of 0-5:

    Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.

    Grade 3:Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed.

    Grade 2: Muscle can move only if the resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.

    Grade 0: No movement is observed. Higher values represent a better outcome. We'd like to asses foot dorsiflexor muscle strength.


  4. Ashworth scale [ Time Frame: 1 minute ]

    Measurement of resistance during passive plantarflexion and dorsiflexion.

    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.


  5. Tinetti test - gait and balance [ Time Frame: 10 minutes ]

    The Tinetti Balance and Gait test is a standardized evaluation of mobility and stability. Balance and gait are assessed and scored individually in a 16-item test. A three-point ordinal scale, ranging from 0-2. "0" indicates the highest level of impairment and "2" the individuals independence. Gait is scored 0-12 and balance is scored 0-16. Total Test Score is maximum 28.

    Interpretation:

    25-28 low fall risk 19-24 medium fall risk < 19 high fall risk Higher score represent a better outcome.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients over 6 months after stroke,
  • tibialis anterior strength (Lovett scale) not less than 1 and not greater than 3,
  • Ashworth scale in tibialis anterior 0,1, 2

Exclusion Criteria:

  • patients less than 6 months after stroke,
  • tibialis anterior strength (Lovett scale) 0, 4, 5,
  • Ashworth scale in tibialis anterior higher than 2,
  • damage to the central nervous system which is another incident,
  • serious cognitive deficit,
  • stiffness of the ankle.

Layout table for additonal information
Responsible Party: Marzena Adamczyk, Investigator, Rehamed Center
ClinicalTrials.gov Identifier: NCT03888118     History of Changes
Other Study ID Numbers: 001
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marzena Adamczyk, Rehamed Center:
Luna EMG
drop foot
chronic stroke

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases