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| Name | Class |
|---|---|
| Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioness-300 | Device | Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Lower motor neuron injury with inadequate response to stimulation
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| Name | Affiliation | Role |
|---|---|---|
| Benedikt Schoser, MD | Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurological Clinic Medicalpark Bad Feilnbach | Bad Feilnbach | Bavaria | 83075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36544079 | Derived | 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. |
| Label | URL |
|---|---|
| homepage Medicalpark Clinics | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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clinical sequential two-period crossover-design study
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |