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

Sponsor
Lithuanian University of Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05187559
Collaborator
(none)
120
1
2
33
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard physiotherapy
  • Device: Biodex Balance SD and Biodex Gait Trainer
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

  3. 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.

  4. 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

  1. 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.

  2. 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.

  3. 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.

  4. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait geometry: Foot rotation(degree)

  5. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait geometry: Step length(cm)

  6. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait geometry:Stride length(cm)

  7. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait geometry: Step width(cm)

  8. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait phases: Stance phase(%)

  9. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait phases: Load response(%)

  10. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait phases: Single limb support(%)

  11. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait phases: Pre-Swing(%)

  12. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait phases: Swing phase(%)

  13. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait phases: Double stance phase(%)

  14. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait timing: Step time(sec)

  15. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait timing: Stride time(sec)

  16. Gait analysis with zebris FDM (score) [Baseline - before enrolling 4 week training program and after 4 week training]

    Analysis of gait timing: Cadence(steps/min)

  17. 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)

  18. 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 (Butterfly parameters): Length of gait line(mm)

  19. 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 (Butterfly parameters): Single limb support line(mm)

  20. 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 (Butterfly parameters): Anterior/posterior position(mm)

  21. 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 (Butterfly parameters): Lateral symmetry(mm)

  22. 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 (Butterfly parameters): Max gait line velocity(cm/sec)

  23. 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 change heel to forefoot(sec)

  24. 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 change heel to forefoot(%)

  25. 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): Maximum force (Forefoot, Midfoot, Heel) (N)

  26. 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): Maximum pressure (Forefoot, Midfoot, Heel) (N/cm²)

  27. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
44 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toma Steponkienė Kaunas Lithuania 47484

Sponsors and Collaborators

  • Lithuanian University of Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Toma Steponkienė, PhD student, Lecturer, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier:
NCT05187559
Other Study ID Numbers:
  • RK-NRB-TS-01
First Posted:
Jan 12, 2022
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Toma Steponkienė, PhD student, Lecturer, Lithuanian University of Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022