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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05187559
Enrollment
120
Registered
2022-01-12
Start date
2021-12-01
Completion date
2024-08-31
Last updated
2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Ischemia, Stroke, Ischemic

Keywords

Brain Ischemia, Stroke, Balance, Gait, Physiotherapy, Physical Therapy, Visual Feedback

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.

Interventions

OTHERStandard physiotherapy

Neuromuscular exercise program with standard physiotherapy with no visual feedback

DEVICEBiodex Balance SD and Biodex Gait Trainer

Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.

Eligibility

Sex/Gender
ALL
Age
44 Years to 74 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle strength by Oxford scaleBaselineTesting 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 ScaleBaselineThe 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 TestBaselinesubjects 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 ScaleBaselineThis scale contains 9 statements that are designed to evaluate the internal and external beliefs regarding the traumatic events that the patient has experienced.

Secondary

MeasureTime frameDescription
Limits of Stability Testing with Biodex SD (score)Baseline - before enrolling 4 week training program and after 4 week trainingDuring 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.
Center of Pressure analysis during step cycles with zebris FDM (score)Baseline - before enrolling 4 week training program and after 4 week trainingCOP analysis (Butterfly parameters): Length of gait line(mm)
Risk of Fall Testing with Biodex SD (score)Baseline - before enrolling 4 week training program and after the whole trainingTest 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)Baseline - before enrolling 4 week training program and after 4 week trainingStance 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)Baseline - before enrolling 4 week training program and after 4 week trainingAnalysis of gait geometry: Foot rotation(degree)

Countries

Lithuania

Contacts

Primary ContactToma Steponkienė
toma.steponkiene@lsmu.lt+37068375252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026