N/A
N=70
Evaluation of Dual Channel vs. Single Channel FES for Dropfoot
Dropfoot
Bottom Line
View on ClinicalTrials.gov: NCT02494323 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE — 3.63 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functional Electrical Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bioness Neuromodulation
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE |
3.63 | — |
| SECONDARY Benefit Satisfaction Willingness to Continue (BSW) Questionnaire |
50; 55; 15; 10; 47; 18 | <0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria:• Experienced user or a new user of Functional Electrical Stimulation devices
- Upper motor neuron lesion.
- Foot drop - toe drag during walking.
- Lower limb spasticity- 0-4 according to the modified Ashworth scale.
- Responsible mental state, able to follow multiple step directions.
- Aged between 18 and 80 years old.
- Available for participating in the study.
- Able to understand and sign the informed consent form.
- Able to walk independently or with an assistance device (e.g. cane, walker etc.) / spot guarding for at least 10 meters.
- Ankle passive range of motion preserved between 10 degrees plantarflexion and 30 degrees dorsiflexion.
Exclusion Criteria
- • Subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant.
- Cancerous lesion of lower limb, present or suspected.
- Medical condition that prevents participation or would likely lead to inability to comply with the protocol [e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc.].
- Skin lesion at the site of the stimulation electrodes.
- Change in bone-joint structures of the lower limb, such as contractures or deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation.
- Pregnancy.
- Diagnosis of major depression or psychotic disorder.
- Participation in another investigation that may directly or indirectly affect the study results.
- Unable to tolerate electrical stimulation.
Data sourced from ClinicalTrials.gov (NCT02494323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.