CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Functional Electrical Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02494323
NCT02494323N/ACompleted

The Evaluation of Dual Channel vs Single Channel FES for Dropfoot

Bioness Neuromodulation·interventional·Posted Jul 10, 2015·Updated Aug 3, 2016

In Brief

A clinical study evaluating Functional Electrical Stimulation for Dropfoot. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDropfoot
CountriesIsrael

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 10, 2015
Enrollment StartMar 1, 2015
Primary CompletionJun 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.0 years ago

Interventions

Functional Electrical Stimulationdevice

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