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

Stroke, Ischemic Clinical Trial

Official title:

Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position During Standing and Walking for Patients With Stroke During the Second Stage of Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187559
• Other study ID #: RK-NRB-TS-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2022
• Source: Lithuanian University of Health Sciences
• Contact: Toma Steponkiene
• Phone: +37068375252
• Email: toma.steponkiene[@]lsmu.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 44 Years to 74 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• Standard physiotherapy
Neuromuscular exercise program with standard physiotherapy with no visual feedback

Device:
• Biodex Balance SD and Biodex Gait Trainer
Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform

Locations

Country	Name	City	State
Lithuania	Toma Steponkiene	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength by Oxford scale	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.	Baseline
Primary	Gait and Balance testing by Berg Scale	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).	Baseline
Primary	Timed Stand Up and Go Test	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.	Baseline
Primary	Recovery Locus of Control Scale	This scale contains 9 statements that are designed to evaluate the internal and external beliefs regarding the traumatic events that the patient has experienced.	Baseline
Secondary	Limits of Stability Testing with Biodex SD (score)	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.	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Risk of Fall Testing with Biodex SD (score)	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.	Baseline - before enrolling 4 week training program and after the whole training
Secondary	Stance analysis with zebris FDM (score)	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.	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait geometry: Foot rotation(degree)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait geometry: Step length(cm)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait geometry:Stride length(cm)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait geometry: Step width(cm)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait phases: Stance phase(%)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait phases: Load response(%)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait phases: Single limb support(%)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait phases: Pre-Swing(%)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait phases: Swing phase(%)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait phases: Double stance phase(%)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait timing: Step time(sec)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait timing: Stride time(sec)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait timing: Cadence(steps/min)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Gait analysis with zebris FDM (score)	Analysis of gait timing: Velocity(km/h)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Butterfly parameters): Length of gait line(mm)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Butterfly parameters): Single limb support line(mm)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Butterfly parameters): Anterior/posterior position(mm)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Butterfly parameters): Lateral symmetry(mm)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Butterfly parameters): Max gait line velocity(cm/sec)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Load change parameters): Time change heel to forefoot(sec)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Load change parameters): Time change heel to forefoot(%)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Load change parameters): Maximum force (Forefoot, Midfoot, Heel) (N)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Load change parameters): Maximum pressure (Forefoot, Midfoot, Heel) (N/cm²)	Baseline - before enrolling 4 week training program and after 4 week training
Secondary	Center of Pressure analysis during step cycles with zebris FDM (score)	COP analysis (Load change parameters): Time maximum force (Forefoot, Midfoot, Heel)(% of stance)	Baseline - before enrolling 4 week training program and after 4 week training