Effects of Functional Electrical Stimulation Device Bioness L300 on the Somatosensory Cortical Neuroplasticity in the Rehabilitation of Patients After Stroke

Overview

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.

Full Title of Study: “Short-term Therapeutic Effects of Functional Electrical Stimulation Device Bioness L300 on the Somatosensory Cortical Representation in the Rehabilitation of Patients After Stroke”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2022

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 studies Feys et al 2000, Sazzad et al. 2013, Tashiro et al. 2019, 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.

Interventions

  • Device: Bioness-300
    • Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.

Arms, Groups and Cohorts

  • Other: Open labele BIONESS-Training
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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]

Secondary Measures

  • Motor score improvement
    • Time Frame: 4 weeks
    • • 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]

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Klinikum der Universitaet Muenchen
  • Collaborator
    • Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Benedikt Schoser, Senior consultant neurologist – Klinikum der Universitaet Muenchen
  • Overall Official(s)
    • Benedikt Schoser, MD, Principal Investigator, Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany
  • Overall Contact(s)
    • Marco Mijic, +49 806618, m.mijic@medicalpark.de

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