Brain IschemiaNCT05187559
Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors
A study testing Standard physiotherapy and Biodex Balance SD and Biodex Gait Trainer in people with Brain Ischemia and Stroke, Ischemic, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 44 to 74 years
- Conditions the study is for
- Brain Ischemia, Stroke, Ischemic
- What is being tested?
- Standard physiotherapy and Biodex Balance SD and Biodex Gait Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Dec 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Toma Steponkienė
Kaunas, 47484
Toma Steponkienė, +37068375252, toma.steponkiene@lsmu.lt
About this study
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
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.
- Conditions
- Brain Ischemia, Stroke, Ischemic
- Being tested
- Standard physiotherapy, Biodex Balance SD and Biodex Gait Trainer
- Keywords
- Brain Ischemia, Stroke, Balance, Gait, Physiotherapy, Physical Therapy, Visual Feedback
- Medical subject headings
- Brain Ischemia, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physiotherapyOther
Neuromuscular exercise program with standard physiotherapy with no visual feedback
Biodex Balance SD and Biodex Gait TrainerDevice
Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform
| Study group | Role | What they receive |
|---|---|---|
| First Group | Experimental | Neuromuscular exercise program with standard physiotherapy with no visual feedback. Receives: Other: Standard physiotherapy |
| Second Group | Experimental | Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform Receives: Device: Biodex Balance SD and Biodex Gait Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Analysis of gait phases: Stance phase(%)
Measured: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Analysis of gait phases: Load response(%)
Measured: 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(%)
Measured: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Analysis of gait phases: Pre-Swing(%)
Measured: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Analysis of gait phases: Swing phase(%)
Measured: 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(%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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(%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline - before enrolling 4 week training program and after 4 week training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Dec 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toma Steponkienė, Lithuanian University of Health Sciences
- Investigators
- Eglė Lendraitienė, PhD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187559
- Sponsor's protocol ID
- RK-NRB-TS-01
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05187559
- Acronym / sponsor ID
- RK-NRB-TS-01
- Conditions
- Brain Ischemia, Stroke, Ischemic
- Keywords
- Brain Ischemia, Stroke, Balance, Gait, Physiotherapy, Physical Therapy, Visual Feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.
| Arm | Type | Receives |
|---|---|---|
| First Group | Experimental | Other: Standard physiotherapyNeuromuscular exercise program with standard physiotherapy with no visual feedback. |
| Second Group | Experimental | Device: Biodex Balance SD and Biodex Gait TrainerNeuromuscular exercise program with physiotherapy with visual feedback using Biodex platform |
Who may qualify
- Ages
- 44 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard physiotherapyNeuromuscular exercise program with standard physiotherapy with no visual feedback | Other | First Group |
| Biodex Balance SD and Biodex Gait TrainerNeuromuscular exercise program with physiotherapy with visual feedback using Biodex platform | Device | Second Group |
Primary outcome
Muscle strength by Oxford scale
Time frame: 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.
Gait and Balance testing by Berg Scale
Time frame: 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).
Timed Stand Up and Go Test
Time frame: 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.
Recovery Locus of Control Scale
Time frame: 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.
27 secondary outcomes
Limits of Stability Testing with Biodex SD (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Risk of Fall Testing with Biodex SD (score)
Time frame: Baseline - before enrolling 4 week training program and after the whole training
Stance analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Gait analysis with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Center of Pressure analysis during step cycles with zebris FDM (score)
Time frame: Baseline - before enrolling 4 week training program and after 4 week training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eglė Lendraitienė, PhD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physiotherapy and Biodex Balance SD and Biodex Gait Trainer in people with Brain Ischemia and Stroke, Ischemic, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Toma Steponkienė (+37068375252, toma.steponkiene@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength by Oxford scale (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.