Effects of BIONESS in Rehabilitation of Stroke

NCT04767360 | Completed

• 1 other identifier: BFB-FBI-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

• Motor score improvement

  4 weeks

Study Arms (1)

Open labele BIONESS-Training

OTHER

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

Device: Bioness-300

Interventions

Bioness-300 DEVICE

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

Open labele BIONESS-Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LMU Klinikum: lead
• Peter Young Neurological Clinic Medicalpark Bad Feilnbach, Germany: collaborator

Study Sites (1)

Neurological Clinic Medicalpark Bad Feilnbach

Bad Feilnbach, Bavaria, 83075, Germany

Location

Related Publications (1)

• Mijic M, Schoser B, Young P. Efficacy of functional electrical stimulation in rehabilitating patients with foot drop symptoms after stroke and its correlation with somatosensory evoked potentials-a crossover randomised controlled trial. Neurol Sci. 2023 Apr;44(4):1301-1310. doi: 10.1007/s10072-022-06561-3. Epub 2022 Dec 21.

  PMID: 36544079 DERIVED

Related Links

• homepage Medicalpark Clinics

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Benedikt Schoser, MD

  Friedrich-Baur-Institute, Dep. of Neurology LMU Klinikum Munich Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant neurologist

Model Details: clinical sequential two-period crossover-design study

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 23, 2021
• Study Start: February 10, 2021
• Primary Completion: October 19, 2021
• Study Completion: December 12, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)