Effects of BIONESS in Rehabilitation of Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Bioness-300

• Registration Number: NCT04767360
• Lead Sponsor: LMU Klinikum

Brief 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.

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 Timeline

• Study Start: 2021-02-10
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-23
• Primary Completion: 2021-10-19
• Study Completion: 2022-12-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Open labele BIONESS-Training	Bioness-300	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

Primary Outcome Measures

Name	Time	Method
SEP measurement	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 Outcome Measures

Name	Time	Method
Motor score improvement	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). \[ Time Frame: Change from baseline at 4 weeks\]

Trial Locations

Locations (1)

Neurological Clinic Medicalpark Bad Feilnbach; 🇩🇪 Bad Feilnbach, Bavaria, Germany