Status:
COMPLETED
Effects of BIONESS in Rehabilitation of Stroke
Lead Sponsor:
LMU Klinikum
Collaborating Sponsors:
Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany
Conditions:
Stroke
Eligibility:
All Genders
18-75 years
Phase:
NA
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"...
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 measur...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04767360
Start Date
February 10 2021
End Date
December 12 2022
Last Update
March 15 2023
Active Locations (1)
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1
Neurological Clinic Medicalpark Bad Feilnbach
Bad Feilnbach, Bavaria, Germany, 83075