Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
Study NCT ID:
NCT04767360
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2021-02-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of BIONESS in Rehabilitation of Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'clinical sequential two-period crossover-design study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-19', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SEP measurement', 'timeFrame': '4 weeks', 'description': 'in improving pathological latencies and / or amplitudes of somatosensory evoked potentials (SEPs)\n\n• N35, P40, N50 (lower limb / tibial nerve) amplitude of somatosensory evoked potential \\[ Time Frame: Change from baseline at 4 weeks\\]'}], 'secondaryOutcomes': [{'measure': 'Motor score improvement', 'timeFrame': '4 weeks', 'description': "• 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\\]"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '36544079', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.medicalpark.de', 'label': 'homepage Medicalpark Clinics'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between the ages of 18 and 75\n* Inadequate ankle dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance\n* Medically stable for at least one week following the last episode of stroke\n* Stable medication for four weeks\n* Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device, and give adequate feedback\n* Ability to walk with or without an assistive device (except parallel bars) at least 10 meters\n\nExclusion Criteria:\n\n* • Lower motor neuron injury with inadequate response to stimulation\n\n * History of falls greater than once a week\n * Severe cardiac disease such as myocardial infarction, congestive heart failure, or a demand pacemaker\n * Patients who have other electrical stimulation devices implemented\n * Patients with epilepsy and with autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT04767360', 'acronym': 'EFES-BIO-SEP', 'briefTitle': 'Effects of BIONESS in Rehabilitation of Stroke', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'Short-term Therapeutic Effects of Functional Electrical Stimulation Device Bioness L300 on the Somatosensory Cortical Representation in the Rehabilitation of Patients After Stroke', 'orgStudyIdInfo': {'id': 'BFB-FBI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open labele BIONESS-Training', 'description': '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', 'interventionNames': ['Device: Bioness-300']}], 'interventions': [{'name': 'Bioness-300', 'type': 'DEVICE', 'description': 'Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.', 'armGroupLabels': ['Open labele BIONESS-Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83075', 'city': 'Bad Feilnbach', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Neurological Clinic Medicalpark Bad Feilnbach', 'geoPoint': {'lat': 47.77331, 'lon': 12.00973}}], 'overallOfficials': [{'name': 'Benedikt Schoser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant neurologist', 'investigatorFullName': 'Prof. Dr. Benedikt Schoser', 'investigatorAffiliation': 'LMU Klinikum'}}}}