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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Ischemia; Stroke, Ischemic
• Intervention / Treatment: Other: Standard physiotherapy; Device: Biodex Balance SD and Biodex Gait Trainer

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Toma Steponkienė; Phone Number: +37068375252; Email: toma.steponkiene@lsmu.lt

Study Locations

• Lithuania
  • Kaunas, Lithuania, 47484
    • Recruiting
    • Toma Steponkienė
    • Contact: Toma Steponkienė; Phone Number: +37068375252; Email: toma.steponkiene@lsmu.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 44 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: First Group; Neuromuscular exercise program with standard physiotherapy with no visual feedback.	Other: Standard physiotherapy; Neuromuscular exercise program with standard physiotherapy with no visual feedback
EXPERIMENTAL: Second Group; Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform	Device: Biodex Balance SD and Biodex Gait Trainer; Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Gait analysis with zebris FDM (score)	Analysis of gait phases: Stance phase(%)	Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)	Analysis of gait phases: Load response(%)	Baseline - before enrolling 4 week training program and after 4 week training
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
Gait analysis with zebris FDM (score)	Analysis of gait phases: Pre-Swing(%)	Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)	Analysis of gait phases: Swing phase(%)	Baseline - before enrolling 4 week training program and after 4 week training
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Principal Investigator: Eglė Lendraitienė, PhD, Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ANTICIPATED): August 31, 2024
• Study Completion (ANTICIPATED): August 31, 2024

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (ACTUAL): January 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Balance; Stroke; Gait; Physical Therapy; Physiotherapy; Brain Ischemia; Visual Feedback
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Brain Ischemia; Ischemia
• Other Study ID Numbers: RK-NRB-TS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No