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

LMU Klinikum

Status: Completed

Conditions: Stroke

Treatments: Device: Bioness-300

Study type: Interventional

Funder types: Other

Identifiers

NCT04767360

BFB-FBI-001

Details and patient eligibility

About

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 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Open labele BIONESS-Training

Other group

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

Treatment:

Device: Bioness-300