StrokeEFES-BIO-SEPNCT04767360
Effects of BIONESS in Rehabilitation of Stroke
A study testing Bioness-300 in people with Stroke, run by LMU Klinikum at 1 site in Germany.
Trial summary
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bioness-300
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2021to 12 Dec 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18 and 75
- Inadequate ankle dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance
- Medically stable for at least one week following the last episode of stroke
- Stable medication for four weeks
- Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device, and give adequate feedback
- Ability to walk with or without an assistive device (except parallel bars) at least 10 meters
Who cannot join
- • Lower motor neuron injury with inadequate response to stimulation
- History of falls greater than once a week
- Severe cardiac disease such as myocardial infarction, congestive heart failure, or a demand pacemaker
- Patients who have other electrical stimulation devices implemented
- Patients with epilepsy and with autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Neurological Clinic Medicalpark Bad Feilnbach
Bad Feilnbach, Bavaria, 83075
About this study
Official title: Short-term Therapeutic Effects of Functional Electrical Stimulation Device Bioness L300 on the Somatosensory Cortical Representation in the Rehabilitation of Patients After Stroke
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.
Read the detailed description
Prediction of motor recovery in the upper-limb (UL) / lower-limb (LL) in patients with stroke is generally based on clinical examination. However, according to former studies neurophysiological measures may also have a predictive value. In the acute phase, the combination of the motor score and SEPs are best predictive of outcome. Neurophysiological measures alone are of limited value in predicting long term outcome. However, predictive accuracy is substantially improved through the combined use of both of these measures and clinical variables.
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.
- Conditions
- Stroke
- Being tested
- Bioness-300
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioness-300Device
Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.
| Study group | Role | What they receive |
|---|---|---|
| Open labele BIONESS-Training | Other | Four-week therapeutic treatment of foot drop with the electrical stimulation device Bioness L300. This treatment will be performed five times a week for at least 30 minutes Receives: Device: Bioness-300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEP measurement
in improving pathological latencies and / or amplitudes of somatosensory evoked potentials (SEPs)
- N35, P40, N50 (lower limb / tibial nerve) amplitude of somatosensory evoked potential [ Time Frame: Change from baseline at 4 weeks]
Measured: 4 weeks
Secondary outcomes (1)
Motor score improvement
- Dorsal flexion/plantar extension of the ankle strength will be measured by Janda's classification of muscle imbalance patterns (Force produced by voluntary dorsiflexion). [ Time Frame: Change from baseline at 4 weeks]
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start10 Feb 2021
- Primary completion19 Oct 2021
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- clinical sequential two-period crossover-design study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany
- Responsible party
- Principal investigator, Prof. Dr. Benedikt Schoser, LMU Klinikum
- Investigators
- Benedikt Schoser, MD, Principal investigator, Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767360
- Sponsor's protocol ID
- BFB-FBI-001
- Acronym
- EFES-BIO-SEP
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mijic M, Schoser B, Young P. Efficacy of functional electrical stimulation in rehabilitating patients with foot drop symptoms after stroke and its correlation with somatosensory evoked potentials-a crossover randomised controlled trial. Neurol Sci. 2023 Apr;44(4):1301-1310. doi: 10.1007/s10072-022-06561-3. Epub 2022 Dec 21.
PubMed 36544079
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Therapeutic Effects of Functional Electrical Stimulation Device Bioness L300 on the Somatosensory Cortical Representation in the Rehabilitation of Patients After Stroke
- ClinicalTrials.gov ID
- NCT04767360
- Acronym / sponsor ID
- EFES-BIO-SEP / BFB-FBI-001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 23 Feb 2021 (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.
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.
Detailed description
Prediction of motor recovery in the upper-limb (UL) / lower-limb (LL) in patients with stroke is generally based on clinical examination. However, according to former studies neurophysiological measures may also have a predictive value. In the acute phase, the combination of the motor score and SEPs are best predictive of outcome. Neurophysiological measures alone are of limited value in predicting long term outcome. However, predictive accuracy is substantially improved through the combined use of both of these measures and clinical variables.
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- clinical sequential two-period crossover-design study
| Arm | Type | Receives |
|---|---|---|
| Open labele BIONESS-Training | Other | Device: Bioness-300Four-week therapeutic treatment of foot drop with the electrical stimulation device Bioness L300. This treatment will be performed five times a week for at least 30 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between the ages of 18 and 75
- Inadequate ankle dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance
- Medically stable for at least one week following the last episode of stroke
- Stable medication for four weeks
- Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device, and give adequate feedback
Key exclusion criteria (5 listed)
- • Lower motor neuron injury with inadequate response to stimulation
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 |
|---|---|---|
| Bioness-300Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300. | Device | Open labele BIONESS-Training |
Primary outcome
SEP measurement
Time frame: 4 weeks
in improving pathological latencies and / or amplitudes of somatosensory evoked potentials (SEPs) • N35, P40, N50 (lower limb / tibial nerve) amplitude of somatosensory evoked potential [ Time Frame: Change from baseline at 4 weeks]
1 secondary outcome
Motor score improvement
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 36544079Mijic M, Schoser B, Young P. Efficacy of functional electrical stimulation in rehabilitating patients with foot drop symptoms after stroke and its correlation with somatosensory evoked potentials-a crossover randomised controlled trial. Neurol Sci. 2023 Apr;44(4):1301-1310. doi: 10.1007/s10072-022-06561-3. Epub 2022 Dec 21.
- homepage Medicalpark ClinicsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Benedikt Schoser, MD principal investigator
Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioness-300 in people with Stroke, run by LMU Klinikum at 1 site in Germany.
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 6 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: finished, as of the sponsor's last update on 15 Mar 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEP measurement (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767360, which also lists 1 linked publication.
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 15 Mar 2023.