Clinical trial NCT04981184: Informative of Surface Electromyography and Prognostic Factors in Assessing the Recovery of Balance and Gait After Stroke
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Ischemia
Keywords: Surface Electromyography
Gait
Balance
Ischemic stroke
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Muscle strength by Oxford scale
timeFrame: Baseline
measure: Gait analysis with surface electromyography: Load change (seconds)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Maximum force (Newton)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Maximum pressure (Newtons /square centimeter (N/cm²))
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Time maximum force (percentage of stance time)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Contact time (percentage of stance time)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Length of the gait line (millimeters)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Anterior/Posterior Position (millimeters)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Lateral symmetry (millimeters)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Step time (seconds)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Cadence (steps/minutes)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Velocity (kilometers/hour)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Stance phase (percentage)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Swing phase (percentage)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Double stance phase (percentage)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Foot rotation (degree)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Step length (centimeters)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Stride length (centimeters)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: Step width (centimeters)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Gait analysis with surface electromyography: surface electromyography signals (microvolts)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Stance analysis: Step width (centimeters)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
Secondary outcomes:
measure: Biodex Balance System (BBS): Postural Stability Test (Overall stability index)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Biodex Balance System (BBS): Limits of Stability Test (seconds)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Biodex Balance System (BBS): Limits of Stability Test (score)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Biodex Balance System (BBS): A fall risk test (scores)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Biodex Balance System (BBS): Clinical Test of Sensory Integration of Balance(CTSIB) (sway index)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
measure: Biodex Balance System (BBS): Balance Error Scoring System (sway index)
timeFrame: Baseline, approximately 2 days before the end of acute rehabilitation
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Study officials:
affiliation: LUHS
name: Eglė Lendraitienė, PhD
role: PRINCIPAL_INVESTIGATOR
References: