Evaluation of Dual Channel vs. Single Channel FES for Dropfoot

NCT02494323 | Completed Results

• 1 other identifier: Segmented Electrodes
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dual Channel Functional Electrical Stimulation; dropfoot, balanced dorsiflexion

Outcome Measures

Primary Outcomes (1)

• Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE

  Subjects were fitted with the L300 Cuff that houses the single channel QFE and then the modified cuff that houses the dual channel segmented electrode. Subjects were stimulated first sitting and then after optimal ankle elevation was achieved, they walked with the stimulation. The clinician documented ankle movement on a 5 point scale: 1-inverted dorsiflexion, 2-slightly inverted dorsiflexion, 3-neutral dorsiflexion,4- slightly everted dorsiflexion, 5- everted dorsiflexion. The clinician documented the number of subjects who achieved each movement with each electrode according to the 5 point scale.

  7 months

Secondary Outcomes (1)

• Benefit Satisfaction Willingness to Continue (BSW) Questionnaire

  7 months

Study Arms (1)

Functional Electrical Stimulation

EXPERIMENTAL

Dual channel stimulation of the peroneal nerve to improve dropfoot

Device: Functional Electrical Stimulation

Interventions

Functional Electrical Stimulation DEVICE

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

Also known as: Segmented Electrode, Novus System

Functional Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioness Neuromodulation: lead
• Loewenstein Hospital: collaborator

Study Sites (1)

Bioness Neuromodulations

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

A spot test, no time adjusting to stimulation, no home use, indoor environment only, muscle fatigue is an influential factor that was not checked.

Results Point of Contact

• Title: Dr.Yaron Sacher
• Organization: Bet-Loewenstein

ysacher@clalit.org.il

97297709918

Study Officials

• Bella Kuchuk

  R&D Clinician

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: July 10, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 3, 2016
• Results First Posted: April 1, 2016

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)