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Evaluation of Dual Channel vs. Single Channel FES for Dropfoot

NCT02494323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-08-03

Study results available
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Summary

Seventy (70) subjects put on the Ness L300 System, a FES device for ankle dorsiflexion for patients with foot drop. Stimulation will be given through two different electrodes: the QFE which is a single channel stimulation, and the Segmented Electrode which is a dual channel electrode. The purpose of the dual channel stimulation is to enable a balanced dorsiflexion, with no inversion/eversion inclinations. Ankle elevation will be recorded both in a seated position and during gait. Subject preference will be recorded through BSW Questionnaire and Subjective Survey. Twenty first subjects will be stimulated with four different dual channel configurations. The configuration that shows to have an advantage over the others will continue to be evaluated on fifty additional subjects. Same procedure will be taken place, in addition ambulation tests will be performed.

Conditions

  • Dropfoot

Interventions

DEVICE

Functional Electrical Stimulation

Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot

Sponsors & Collaborators

  • Loewenstein Hospital

    collaborator OTHER

  • Bioness Neuromodulation

    lead INDUSTRY

Principal Investigators

  • Bella Kuchuk · R&D Clinician

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-06-30
Completion
2016-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02494323 on ClinicalTrials.gov