Effects of BIONESS in Rehabilitation of Stroke

Stroke Clinical Trial

— EFES-BIO-SEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767360
• Other study ID #: BFB-FBI-001
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: December 12, 2022

Study information

• Verified date: March 2023
• Source: LMU Klinikum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). "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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 12, 2022
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Germany	Neurological Clinic Medicalpark Bad Feilnbach	Bad Feilnbach	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
LMU Klinikum	Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   homepage Medicalpark Clinics