Effects of BIONESS in Rehabilitation of Stroke (EFES-BIO-SEP)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Bioness-300

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Mijic; Phone Number: 7250 +49 806618; Email: m.mijic@medicalpark.de
• Study Contact Backup: Name: Peter Young, MD; Email: p.young@medicalpark.de

Study Locations

• Germany
  • Bavaria
    • Bad Feilnbach, Bavaria, Germany, 83075
      • Neurological Clinic Medicalpark Bad Feilnbach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Bioness-300; Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Collaborators: Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany
• Investigators: Principal Investigator: Benedikt Schoser, MD, Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany

Publications and helpful links

Helpful Links

• homepage Medicalpark Clinics

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): October 19, 2021
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: BFB-FBI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No