Brain IschemiaNCT04981184
Informative of Surface Electromyography and Prognostic Factors in Assessing the Recovery of Balance and Gait After Stroke
A study testing Gait and balance measurement in people with Brain Ischemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- Gait and balance measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 22 Jul 2019to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Kaunas
Ieva Žemaitienė, +37064850958, ieva.zemaitiene@lsmu.lt
About this study
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
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.
- Conditions
- Brain Ischemia
- Being tested
- Gait and balance measurement
- Keywords
- Surface Electromyography, Gait, Balance, Ischemic stroke
- Medical subject headings
- Brain Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait and balance measurementDevice
Virtual gait training procedures are included. Balance training procedures with Biodex Balance system are included too.
| Study group | Role | What they receive |
|---|---|---|
| Gait and balance measurement | Other | 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. Receives: Device: Gait and balance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Gait analysis with surface electromyography: Load change (seconds)
Time change heel to forefoot.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, approximately 2 days before the end of acute rehabilitation
Gait analysis with surface electromyography: Cadence (steps/minutes)
Change from baseline of step frequency.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, approximately 2 days before the end of acute rehabilitation
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, approximately 2 days before the end of acute rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start22 Jul 2019
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ieva Žemaitienė, Lithuanian University of Health Sciences
- Investigators
- Eglė Lendraitienė, PhD, Principal investigator, LUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981184
- Sponsor's protocol ID
- BE-2-67
- Status last verified
- Oct 2024
- First submitted
- 3 Jul 2021
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04981184
- Acronym / sponsor ID
- BE-2-67
- Conditions
- Brain Ischemia
- Keywords
- Surface Electromyography, Gait, Balance, Ischemic stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait and balance measurement | Other | Device: Gait and balance measurementGait 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait and balance measurementVirtual gait training procedures are included. Balance training procedures with Biodex Balance system are included too. | Device | Gait and balance measurement |
Primary outcome
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.
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.
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.
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).
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Biodex Balance System (BBS): Postural Stability Test (Overall stability index)
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Limits of Stability Test (seconds)
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Limits of Stability Test (score)
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): A fall risk test (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)
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Biodex Balance System (BBS): Balance Error Scoring System (sway index)
Time frame: Baseline, approximately 2 days before the end of acute rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eglė Lendraitienė, PhD principal investigator
LUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait and balance measurement in people with Brain Ischemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ieva Žemaitienė, MCs (+37064850985, ieva.zemaitiene@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength by Oxford scale (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.