Back to resultsEffectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors
Primary Purpose
Brain Ischemia, Stroke, Ischemic
Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Standard physiotherapy
Biodex Balance SD and Biodex Gait Trainer
Sponsored by
About this trial
This is an interventional treatment trial for Brain Ischemia focused on measuring Brain Ischemia, Stroke, Balance, Gait, Physiotherapy, Physical Therapy, Visual Feedback
Eligibility Criteria
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.
Sites / Locations
- Toma SteponkienėRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First Group
Second Group
Arm Description
Neuromuscular exercise program with standard physiotherapy with no visual feedback.
Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform
Outcomes
Primary Outcome Measures
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.
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).
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.
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.
Secondary Outcome Measures
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.
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.
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.
Gait analysis with zebris FDM (score)
Analysis of gait geometry: Foot rotation(degree)
Gait analysis with zebris FDM (score)
Analysis of gait geometry: Step length(cm)
Gait analysis with zebris FDM (score)
Analysis of gait geometry:Stride length(cm)
Gait analysis with zebris FDM (score)
Analysis of gait geometry: Step width(cm)
Gait analysis with zebris FDM (score)
Analysis of gait phases: Stance phase(%)
Gait analysis with zebris FDM (score)
Analysis of gait phases: Load response(%)
Gait analysis with zebris FDM (score)
Analysis of gait phases: Single limb support(%)
Gait analysis with zebris FDM (score)
Analysis of gait phases: Pre-Swing(%)
Gait analysis with zebris FDM (score)
Analysis of gait phases: Swing phase(%)
Gait analysis with zebris FDM (score)
Analysis of gait phases: Double stance phase(%)
Gait analysis with zebris FDM (score)
Analysis of gait timing: Step time(sec)
Gait analysis with zebris FDM (score)
Analysis of gait timing: Stride time(sec)
Gait analysis with zebris FDM (score)
Analysis of gait timing: Cadence(steps/min)
Gait analysis with zebris FDM (score)
Analysis of gait timing: Velocity(km/h)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Butterfly parameters): Length of gait line(mm)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Butterfly parameters): Single limb support line(mm)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Butterfly parameters): Anterior/posterior position(mm)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Butterfly parameters): Lateral symmetry(mm)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Butterfly parameters): Max gait line velocity(cm/sec)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Load change parameters): Time change heel to forefoot(sec)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Load change parameters): Time change heel to forefoot(%)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Load change parameters): Maximum force (Forefoot, Midfoot, Heel) (N)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Load change parameters): Maximum pressure (Forefoot, Midfoot, Heel) (N/cm²)
Center of Pressure analysis during step cycles with zebris FDM (score)
COP analysis (Load change parameters): Time maximum force (Forefoot, Midfoot, Heel)(% of stance)
Full Information
NCT ID
NCT05187559
First Posted
November 22, 2021
Last Updated
January 7, 2022
Sponsor
Lithuanian University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05187559
Brief Title
Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia, Stroke, Ischemic
Keywords
Brain Ischemia, Stroke, Balance, Gait, Physiotherapy, Physical Therapy, Visual Feedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
First Group
Arm Type
Experimental
Arm Description
Neuromuscular exercise program with standard physiotherapy with no visual feedback.
Arm Title
Second Group
Arm Type
Experimental
Arm Description
Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy
Intervention Description
Neuromuscular exercise program with standard physiotherapy with no visual feedback
Intervention Type
Device
Intervention Name(s)
Biodex Balance SD and Biodex Gait Trainer
Intervention Description
Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform
Primary Outcome Measure Information:
Title
Muscle strength by Oxford scale
Description
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.
Time Frame
Baseline
Title
Gait and Balance testing by Berg Scale
Description
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).
Time Frame
Baseline
Title
Timed Stand Up and Go Test
Description
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.
Time Frame
Baseline
Title
Recovery Locus of Control Scale
Description
This scale contains 9 statements that are designed to evaluate the internal and external beliefs regarding the traumatic events that the patient has experienced.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Limits of Stability Testing with Biodex SD (score)
Description
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.
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Risk of Fall Testing with Biodex SD (score)
Description
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.
Time Frame
Baseline - before enrolling 4 week training program and after the whole training
Title
Stance analysis with zebris FDM (score)
Description
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.
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait geometry: Foot rotation(degree)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait geometry: Step length(cm)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait geometry:Stride length(cm)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait geometry: Step width(cm)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait phases: Stance phase(%)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait phases: Load response(%)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait phases: Single limb support(%)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait phases: Pre-Swing(%)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait phases: Swing phase(%)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait phases: Double stance phase(%)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait timing: Step time(sec)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait timing: Stride time(sec)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait timing: Cadence(steps/min)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Gait analysis with zebris FDM (score)
Description
Analysis of gait timing: Velocity(km/h)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Butterfly parameters): Length of gait line(mm)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Butterfly parameters): Single limb support line(mm)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Butterfly parameters): Anterior/posterior position(mm)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Butterfly parameters): Lateral symmetry(mm)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Butterfly parameters): Max gait line velocity(cm/sec)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Load change parameters): Time change heel to forefoot(sec)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Load change parameters): Time change heel to forefoot(%)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Load change parameters): Maximum force (Forefoot, Midfoot, Heel) (N)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Load change parameters): Maximum pressure (Forefoot, Midfoot, Heel) (N/cm²)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
Title
Center of Pressure analysis during step cycles with zebris FDM (score)
Description
COP analysis (Load change parameters): Time maximum force (Forefoot, Midfoot, Heel)(% of stance)
Time Frame
Baseline - before enrolling 4 week training program and after 4 week training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toma Steponkienė
Phone
+37068375252
Email
toma.steponkiene@lsmu.lt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eglė Lendraitienė, PhD
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toma Steponkienė
City
Kaunas
ZIP/Postal Code
47484
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toma Steponkienė
Phone
+37068375252
Email
toma.steponkiene@lsmu.lt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors
We'll reach out to this number within 24 hrs