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Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Luna EMG
Sponsored by
Rehamed Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Luna EMG, drop foot, chronic stroke

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study Group

    Control group

    Arm Description

    A four-week rehabilitation program (Monday to Friday) involving the hour of individual ankle therapy and one hour therapy on the Luna EMG device.

    A four-week rehabilitation program (Monday to Friday) involving two hours of individual ankle therapy.

    Outcomes

    Primary Outcome Measures

    EMG using the Luna EMG
    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).
    EMG using the Luna EMG
    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).
    Lovett scale
    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.
    Ashworth scale
    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.
    Tinetti test - gait and balance
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 19, 2019
    Last Updated
    March 20, 2019
    Sponsor
    Rehamed Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03888118
    Brief Title
    Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke
    Official Title
    Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    August 30, 2019 (Anticipated)
    Study Completion Date
    March 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rehamed Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Luna EMG, drop foot, chronic stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    A four-week rehabilitation program (Monday to Friday) involving the hour of individual ankle therapy and one hour therapy on the Luna EMG device.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    A four-week rehabilitation program (Monday to Friday) involving two hours of individual ankle therapy.
    Intervention Type
    Device
    Intervention Name(s)
    Luna EMG
    Intervention Description
    The duration of the overall therapeutic intervention in both groups will be the same.
    Primary Outcome Measure Information:
    Title
    EMG using the Luna EMG
    Description
    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).
    Time Frame
    3 minutes
    Title
    EMG using the Luna EMG
    Description
    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).
    Time Frame
    1 minute
    Title
    Lovett scale
    Description
    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.
    Time Frame
    1 minute
    Title
    Ashworth scale
    Description
    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.
    Time Frame
    1 minute
    Title
    Tinetti test - gait and balance
    Description
    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.
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke

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