Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Informative of Surface Electromyography and Prognostic Factors in Assessing the Recovery of Balance and Gait 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: NCT04981184
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Ieva Žemaitienė, Lithuanian University of Health Sciences

Brief Summary:
The aim of the biomedical research is to determine the informativeness and prognostic factors of surface electromyography by assessing the probability of recovery of balance and gait parameters in the second stage of rehabilitation of persons with cerebral infarction.

Condition or disease Intervention/treatment Phase
Brain Ischemia Device: Gait and balance measurement Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Informative of Surface Electromyography and Determination of Prognostic Factors in Assessing the Probability of Recovery of Balance and Gait Parameters in Patients With Ischemic Stroke on Acute Rehabilitation
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Arm Intervention/treatment
Gait and balance measurement

Gait analysis with surface electromyography measurement: surface electromyography signals (of affected and non-affected legs), gait and stance parameters are collected while the patient walks for 30 seconds on the treadmill with integrated sensor equipment (for measuring the force distribution).

Balance analysis with Biodex balance system SD: measurements of postural stability, fall risk, limits of stability, sensory integration are collected.

Device: Gait and balance measurement
Virtual gait training procedures are included. Balance training procedures with Biodex Balance system are included too.




Primary Outcome Measures :
  1. Muscle strength by Oxford scale [ Time Frame: Baseline ]
    Testing key muscles from the lower extremities (muscle rectus femoris, muscle biceps femoris, muscle gastrocnemius, lateral head, muscle tibialis anterior) against the examiner's resistance and grading the patient's strength on a 0 (No contraction) to 5 (Movement against gravity with full resistance) scale.

  2. Gait analysis with surface electromyography: Load change (seconds) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Time change heel to forefoot.

  3. Gait analysis with surface electromyography: Maximum force (Newton) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The average maximum force change reached in N/cm² for the three zones: toes, mid-foot and heel.

  4. Gait analysis with surface electromyography: Maximum pressure (Newtons /square centimeter (N/cm²)) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The average maximum pressure reached in N/cm² for the three zones: toes, mid-foot and heel (left and right legs separately).

  5. Gait analysis with surface electromyography: Time maximum force (percentage of stance time) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The change of the average point in time within a gait cycle where the maximum values for the three zones: toes, mid-foot and heel were collected in Newton.

  6. Gait analysis with surface electromyography: Contact time (percentage of stance time) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The average contact time change of the three zone toes, mid-foot and heel as a percentage.

  7. Gait analysis with surface electromyography: Length of the gait line (millimeters) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The change from baseline of the progression of the center of pressure of all the steps recorded of one side of the body (left and right side of body separately).

  8. Gait analysis with surface electromyography: Anterior/Posterior Position (millimeters) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The shift change forwards or backwards of the Center of pressure.

  9. Gait analysis with surface electromyography: Lateral symmetry (millimeters) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The change from baseline of the left /right shift of the center of pressure, taking all the steps into consideration. A negative value indicates a shift to the left, and a positive value, a shift to the right.

  10. Gait analysis with surface electromyography: Step time (seconds) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Time change during the phase within a gait cycle between the heel contact of one side of the body and the heel contact of the contralateral side.

  11. Gait analysis with surface electromyography: Cadence (steps/minutes) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Change from baseline of step frequency.

  12. Gait analysis with surface electromyography: Velocity (kilometers/hour) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Average gait speed change from baseline during the analyzed measuring interval (30 seconds).

  13. Gait analysis with surface electromyography: Stance phase (percentage) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The phase of a gait cycle change in which the foot has contact with the ground.

  14. Gait analysis with surface electromyography: Swing phase (percentage) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Change from baseline of the phase of a gait cycle during which the foot has no contact with the ground.

  15. Gait analysis with surface electromyography: Double stance phase (percentage) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The phase change from baseline during a gait cycle that begins at contralateral initial contact (when the heel of the contralateral side touches the ground) and ends at toe off of the viewed side of the body.

  16. Gait analysis with surface electromyography: Foot rotation (degree) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The change from baseline of the angle between the longitudinal axis of the foot and the walking direction.

  17. Gait analysis with surface electromyography: Step length (centimeters) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Change of the distance between the heel contact of one side of the body and the heel contact of the contralateral side.

  18. Gait analysis with surface electromyography: Stride length (centimeters) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    the distance change between two heel contacts on the same side of the body.

  19. Gait analysis with surface electromyography: Step width (centimeters) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The distance change between the right and left foot.

  20. Gait analysis with surface electromyography: surface electromyography signals (microvolts) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Surface electromyography measurements of key muscles (muscle rectus femoris, muscle biceps femoris, muscle gastrocnemius, lateral head, muscle tibialis anterior) with a disposable dual surface electrode. Change of surface electromyography signals during walking on treadmill for 30 seconds.

  21. Stance analysis: Step width (centimeters) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Change from baseline of the averaged load distribution of the left and right forefoot or heel, as well as the load distribution of the left and right contact surface in per cent.


Secondary Outcome Measures :
  1. Biodex Balance System (BBS): Postural Stability Test (Overall stability index) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The BBS will be used to assess postural performance of participants. The movable platform of the BBS allows up to 20° of surface tilt in anterior-posterior and medial-lateral directions. The device is equipped with computer software (Biodex, version 3.1; Biodex Medical Systems). Platform Setting 8. Test Trial Time 20 secs. A high number is indicative of a lot of motion, which is indicative of the patient having trouble balancing. Change from baseline postural stability by overall stability index.

  2. Biodex Balance System (BBS): Limits of Stability Test (seconds) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    During test, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. Platform Setting STATIC. Direction control - OVERALL. Faster - better. Time change of limit of stability test.

  3. Biodex Balance System (BBS): Limits of Stability Test (score) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    During test, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. Platform Setting STATIC. Direction control - OVERALL. The goal - 65 scores and more. Score change of limit of stability test.

  4. Biodex Balance System (BBS): A fall risk test (scores) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    Test results are compared to age dependent normative data. Scores higher than normative values suggest further assessment. Platform Setting 12-8. Test Trial Time 20 seconds. Direction control - OVERALL. Patient's aged 54-71 years' normative scores are 0.9-3.7 scores, 72-89 years' normative scores are 2-4 scores, 36-53 years' normative scores are 0.7-3.1 scores, 17-35 years' normative scores are 0.7-2.1 scores. Change from baseline a fall risk by scores.

  5. Biodex Balance System (BBS): Clinical Test of Sensory Integration of Balance(CTSIB) (sway index) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    The test assesses how well a patient can integrate sensory information to maintain balance. Change from baseline the CTSIB test by the patient's sway index, which represents the mean absolute deviation of the patient's average position during a test. The higher the sway index, the more unsteady the person was during the test. Test Trial Time 30 seconds. The test performs with the patient standing on a firm and foam platform with the eyes open and closed. Measure Sway index of Composite Score.

  6. Biodex Balance System (BBS): Balance Error Scoring System (sway index) [ Time Frame: Baseline, approximately 2 days before the end of acute rehabilitation ]
    A test consists of three positions (Double Leg Stance, Single Leg Stance and Tandem Leg Stance) on two types of platforms (firm and foam) for a total of six conditions. With the Balance System SD, time and error counting is replaced with a measure of sway. Change from baseline balancing errors by Sway index of Composite Score. The higher the sway index, the more unsteady the person was during the test. Test Trial Time 20 seconds



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:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cerebral infarction for the first time;
  • Age from 18 to 89 years old;
  • Muscle strength according to the Oxford scale is 3-5 points;
  • Able to walk without the help of others;
  • Is able to communicate and understand instructions properly;
  • Agrees to participate in the study (voluntary, explicit, informed written consent to participate).

Exclusion Criteria:

  • Muscle strength according to the Oxford scale is 0-2 points;
  • Unable to walk without the help of others;
  • Sensorimotor aphasia or other perceptual disorders;
  • Do not sign the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981184


Contacts
Layout table for location contacts
Contact: Ieva Žemaitienė, MCs +37064850985 ieva.zemaitiene@lsmu.lt

Locations
Layout table for location information
Lithuania
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva Recruiting
Kaunas, Lithuania
Contact: Ieva Žemaitienė    +37064850958    ieva.zemaitiene@lsmu.lt   
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Eglė Lendraitienė, PhD LUHS
Layout table for additonal information
Responsible Party: Ieva Žemaitienė, Ieva Žemaitienė, PT, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT04981184    
Other Study ID Numbers: BE-2-67
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Ieva Žemaitienė, Lithuanian University of Health Sciences:
Surface Electromyography
Gait
Balance
Ischemic stroke
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Ischemia
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes