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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Gait analysis with surface electromyography: Load change (seconds)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Gait and balance measurement (Device)
Outcomes
Primary Outcomes
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: 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.
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: 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.
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: 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: 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: 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: 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: 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: 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: 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: 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.
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 Outcomes
- Biodex Balance System (BBS): Postural Stability Test (Overall stability index)(Baseline, approximately 2 days before the end of acute rehabilitation)
- Biodex Balance System (BBS): Limits of Stability Test (seconds)(Baseline, approximately 2 days before the end of acute rehabilitation)
- Biodex Balance System (BBS): Limits of Stability Test (score)(Baseline, approximately 2 days before the end of acute rehabilitation)
- Biodex Balance System (BBS): A fall risk test (scores)(Baseline, approximately 2 days before the end of acute rehabilitation)
- Biodex Balance System (BBS): Clinical Test of Sensory Integration of Balance(CTSIB) (sway index)(Baseline, approximately 2 days before the end of acute rehabilitation)
- Biodex Balance System (BBS): Balance Error Scoring System (sway index)(Baseline, approximately 2 days before the end of acute rehabilitation)
Investigators
Ieva Žemaitienė
Ieva Žemaitienė, PT
Lithuanian University of Health Sciences