An interventional study of Gait and balance measurement in Brain Ischemia, sponsored by Lithuanian University of Health Sciences. Recruiting at 1 site in Lithuania. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Lithuanian University of Health Sciences · Not applicable, Interventional, and Diagnostic
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.
217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 140 interventional studies indexed under Brain Ischemia.
Browse Brain Ischemia studies →Lithuanian University of Health Sciences is the lead sponsor of 105 studies on the registry; 32 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Muscle strength by Oxford scale
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.
Time frame: Baseline
Gait analysis with surface electromyography: Load change (seconds)
Time change heel to forefoot.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Maximum force (Newton)
The average maximum force change reached in N/cm² for the three zones: toes, mid-foot and heel.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Maximum pressure (Newtons /square centimeter (N/cm²))
The average maximum pressure reached in N/cm² for the three zones: toes, mid-foot and heel (left and right legs separately).
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Time maximum force (percentage of stance time)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Contact time (percentage of stance time)
The average contact time change of the three zone toes, mid-foot and heel as a percentage.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Length of the gait line (millimeters)
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).
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Anterior/Posterior Position (millimeters)
The shift change forwards or backwards of the Center of pressure.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Lateral symmetry (millimeters)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Step time (seconds)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Cadence (steps/minutes)
Change from baseline of step frequency.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Velocity (kilometers/hour)
Average gait speed change from baseline during the analyzed measuring interval (30 seconds).
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Stance phase (percentage)
The phase of a gait cycle change in which the foot has contact with the ground.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Swing phase (percentage)
Change from baseline of the phase of a gait cycle during which the foot has no contact with the ground.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Double stance phase (percentage)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Foot rotation (degree)
The change from baseline of the angle between the longitudinal axis of the foot and the walking direction.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Step length (centimeters)
Change of the distance between the heel contact of one side of the body and the heel contact of the contralateral side.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Stride length (centimeters)
the distance change between two heel contacts on the same side of the body.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Step width (centimeters)
The distance change between the right and left foot.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: surface electromyography signals (microvolts)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Stance analysis: Step width (centimeters)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Postural Stability Test (Overall stability index)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Limits of Stability Test (seconds)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Limits of Stability Test (score)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): A fall risk test (scores)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Clinical Test of Sensory Integration of Balance(CTSIB) (sway index)
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.
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Balance Error Scoring System (sway index)
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
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
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