Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors

Not Applicable

Recruiting

• Conditions: Brain Ischemia; Stroke, Ischemic
• Interventions: Device: Biodex Balance SD and Biodex Gait Trainer; Other: Standard physiotherapy

• Registration Number: NCT05187559
• Lead Sponsor: Lithuanian University of Health Sciences

Brief Summary

The aim of the biomedical research is to evaluate the changes of body position management during standing and walking for stroke patients, using innovative training methods during the rehabilitation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study Start: 2021-12-01
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Experienced an ischemic stroke for the first time;
• Middle-aged (44-59) and elderly (60-74) by WHO classification;
• Muscle strength of the lower extremities according to the Oxford scale is 3-5 points;
• Do not have any neglect;
• Mini Mental State Examination >12 points.

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Exclusion Criteria

• Experienced an ischemic stroke not for the first time;
• Had hip or knee replacement surgery's, which may affect gait;
• Muscle strength of the lower extremities according to the Oxford scale is 0-2 points;
• Have neglect;
• Mini Mental State Examination <12 points.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Second Group	Biodex Balance SD and Biodex Gait Trainer	Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform
First Group	Standard physiotherapy	Neuromuscular exercise program with standard physiotherapy with no visual feedback.

Primary Outcome Measures

Name	Time	Method
Muscle strength by Oxford scale	Baseline	Testing key muscles from the lower and upper extremities 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 and Balance testing by Berg Scale	Baseline	The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It consists of 14 items scored on an ordinal scale of 0 to 4 for a total of 56 points (a higher score indicates lower fall risk).
Timed Stand Up and Go Test	Baseline	subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. 314. The test is a reliable and valid test for quantifying functional mobility that may also be useful in following clinical change over time.
Recovery Locus of Control Scale	Baseline	This scale contains 9 statements that are designed to evaluate the internal and external beliefs regarding the traumatic events that the patient has experienced.

Secondary Outcome Measures

Name	Time	Method
Gait analysis with zebris FDM (score)	Baseline - before enrolling 4 week training program and after 4 week training	Analysis of gait timing: Velocity(km/h)
Limits of Stability Testing with Biodex SD (score)	Baseline - before enrolling 4 week training program and after 4 week training	During test, patients must shift their weight to move the cursor from the center target to a colored target and back as quickly and with as little deviation as possible. Platform Setting- static. Direction control - overall. Faster and accurately- better.
Stance analysis with zebris FDM (score)	Baseline - before enrolling 4 week training program and after 4 week training	Stance phase analysis (stance parameters and forces) - average load distribution under the feet is displayed in color. The color scale enables the load distribution to be quantified. The central point's show the centers of pressure (COP) over the time. The left and right points are the respective centers of pressure of the left and right contact areas. The area of the displayed confidence ellipse contains 95% of the COP's measuring points.
Risk of Fall Testing with Biodex SD (score)	Baseline - before enrolling 4 week training program and after the whole training	Test results are compared to age dependent normative data. Platform Setting - static. Test Trial Time 30 seconds in four positions: eyes opened narrow stance, eyes closed narrow stance, eyes opened closed feet stance, eyes closed stance. 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 indicates a fall risk by scores.
Center of Pressure analysis during step cycles with zebris FDM (score)	Baseline - before enrolling 4 week training program and after 4 week training	COP analysis (Load change parameters): Time maximum force (Forefoot, Midfoot, Heel)(% of stance)

Trial Locations

Locations (1)

Toma Steponkienė; 🇱🇹 Kaunas, Lithuania