Evaluation of Dual Channel vs. Single Channel FES for Dropfoot

Dropfoot Clinical Trial

Official title:

The Evaluation of Dual Channel vs Single Channel FES for Dropfoot

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02494323
• Other study ID #: Segmented Electrodes
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 23, 2015
• Last updated: July 8, 2015
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: February 2015
• Source: Bioness Neuromodulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

20 users of Ness L300, FES device for ankle dorsiflexion will wear the same FES cuff, yet instead of a single channel stimulation, they will be stimulated with two channels. the purpose of the dual channel stimulation is to enable a balanced dorsiflexion, with no inversion/eversion movements. the stimulation will be recorded both in a seated position and during gait

Description:

twenty subjects will be stimulated with a single channel electrode, the Quick Fit Electrode. the values of stimulation will be recorded, as well as ankle movement (balanced Dorsiflexion, inverted or everted Dorsiflexion). Subjects will fill up a Benefit, Satisfaction, Willingness to continue (BSW) form. Next, subjects will be fitted with a segmented Electrode that enables both single and dual channel. Four configurations of current will be compared during sitting position and during gait. The first configuration (A) is segmented electrode single channel stimulation, the second configuration (B) is two currents running in parallel. The first medial channel stimulates the deep branch of common peroneal nerve (dorsiflexion/inversion) and the second lateral current stimulates the superficial peroneal nerve (eversion). In the third configuration (C), channels run diagonally. The medial channel runs between the upper medial electrode and the lateral lower electrode (dorsiflexion/inversion). The lateral channel runs between the lateral upper electrode and the medial lower electrode (eversion). The forth configuration (D) includes a common lower electrode; when it is connected to the upper medial electrode it functions as a medial channel (dorsiflexion/inversion); when it is connected to the upper lateral electrode, it functions as the lateral channel (eversion). The subjects will be asked to answer 3 questions after trying each configuration. 1. Thinking of the current system you use, did this test system provide any difference in the way the stimulation feels compared to your existing system? Yes No/Cannot tell any difference. 2. Thinking of the current system you use, did this test system provide any difference in what you think of as the 'quality' of stimulation you are used to compared to your existing system? Yes No/Cannot tell any difference. 3. Thinking of the current system you use, did this test system provide any difference in your ability to walk compared to your existing system? Yes No/Cannot tell any difference After all three dual channel configurations have been tested, subjects will be asked Question 4: Thinking of the last three test systems you used today, which test system do you believe was best among the three? B, C or D Subjects will be asked to grade their satisfaction with the one dual channel system they believe is best using the Benefit, Satisfaction, Willingness to Continue (BSW) questionnaire.

Phase II of the trial will be a re-evaluation of 10 subjects. The anode/cathode electrodes will be re-positioned so the cathodes will be located at the upper part of the cuff and the anodes will be located at the lower part of the cuff. Stimulation will be given while sitting and during 2 minutes walk. Ankle movement and stimulation intensity will be recorded and compared to the input in phase I for the same users.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:• Experienced 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dropfoot

Intervention

Device:
• Functional Electrical Stimulation
Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot

Locations

Country	Name	City	State
Israel	Bioness Neuromodulations	Hod HAsharon

Sponsors (2)

Lead Sponsor	Collaborator
Bioness Neuromodulation	Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle movement as good as or better with the segmented electrode as with the quickfit electrode		3 months	No
Secondary	Benefit, Satisfaction, Willingness to Continue (BSW) Questionnaire	Questionnaire shows favorable results	3 months	No