Effects of BIONESS in Rehabilitation of Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2022-12-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

clinical sequential two-period crossover-design study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open labele BIONESS-Training

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

Group Type OTHER

Bioness-300

Intervention Type DEVICE

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

Interventions

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Bioness-300

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No