Effects of BIONESS in Rehabilitation of Stroke

LMU Klinikum32 enrolled

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Bioness-300DEVICE

Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Neurological Clinic Medicalpark Bad Feilnbach

Bad Feilnbach, Bavaria, Germany

Outcomes

Primary Outcomes

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 \[ Time Frame: Change from baseline at 4 weeks\]

Time frame: 4 weeks

Secondary Outcomes

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). \[ Time Frame: Change from baseline at 4 weeks\]

Time frame: 4 weeks

Data from ClinicalTrials.gov

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