Clinical trial NCT04767360: Effects of BIONESS in Rehabilitation of Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany
First posted: 2021-02-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: clinical sequential two-period crossover-design study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: SEP measurement
timeFrame: 4 weeks
Secondary outcomes:
measure: Motor score improvement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bad Feilnbach
country: Germany
facility: Neurological Clinic Medicalpark Bad Feilnbach
state: Bavaria
Study officials:
affiliation: Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany
name: Benedikt Schoser, MD
role: PRINCIPAL_INVESTIGATOR
References: