Informative of Surface Electromyography and Prognostic Factors in Assessing the Recovery of Balance and Gait After Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorLithuanian University of Health Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Gait and balance measurement

    Device

    Virtual gait training procedures are included. Balance training procedures with Biodex Balance system are included too.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Gait and balance measurementOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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