Treating Foot Drop in People With Multiple Sclerosis Using Electrical Stimulation

NCT02123537 | Completed

• 1 other identifier: MSFD2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

People with multiple sclerosis (MS) often suffer from foot drop, which impairs their walking ability. Foot drop is the inability to lift the foot during the swing phase of walking. The purpose of this study is to find out if electrical stimulation of the leg, using the Bioness L300 Foot Drop System, can be used to treat foot drop in people with MS. It is expected that using this system will reduce foot drop, and therefore improve walking ability, particularly in the areas of speed, strength, balance and falls.

Conditions

Multiple Sclerosis; Foot Drop

Keywords

Bioness L300 Foot Drop System; Functional electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Speed during the 10-metre straight line walking test

  During the 10-metre straight line walking test, participants walk 10 metres, as marked on the floor with tape, at a steady, self-selected pace, with room for acceleration and deceleration before and after the test. The test measures walking speed, which assesses overall gait function and stability. Participants will complete this test both with and without using the L300 device.

  12 weeks

Secondary Outcomes (10)

• Distance travelled during the 4-minute figure-8 walking test

  12 weeks

• Speed during the 10-metre straight line walking test

  4 weeks

• Speed during the 10-metre straight line walking test

  8 weeks

• Distance travelled during the 4-minute figure-8 walking test

  4 weeks

• Distance travelled during the 4-minute figure-8 walking test

  8 weeks

Study Arms (1)

Bioness L300 Foot Drop System

EXPERIMENTAL

Participants will use the Bioness L300 Foot Drop System for walking daily during the 12 weeks of the study.

Device: Bioness L300 Foot Drop System

Interventions

Bioness L300 Foot Drop System DEVICE

Participants will use the Bioness L300 Foot Drop System during waking hours for 12 weeks.

Bioness L300 Foot Drop System

Eligibility Criteria

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

You may qualify if:

• Have multiple sclerosis for at least one year
• Being 18 years of age or older
• Have upper motor neuron-type foot drop (based on the study clinician's medical opinion)
• Able to ambulate at least 10 metres independently or with one person assistance, with or without walking aid
• Having the cognitive capacity to understand and follow the study protocol

You may not qualify if:

• Severe cardio-respiratory difficulties (including using a pace-maker) or other health issues that may prohibit walking training
• Significant lower motor neuron neuropathy (based on the study clinician's medical opinion)
• History of frequent falls (more than once a week)
• Having used functional electrical stimulation to treat gait within the past six months

Sponsors & Collaborators

• University of Manitoba: lead
• Riverview Health Centre Foundation: collaborator

Study Sites (1)

Rehabilitation Hospital, Health Sciences Centre

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Related Publications (4)

• Laufer Y, Hausdorff JM, Ring H. Effects of a foot drop neuroprosthesis on functional abilities, social participation, and gait velocity. Am J Phys Med Rehabil. 2009 Jan;88(1):14-20. doi: 10.1097/PHM.0b013e3181911246.

  PMID: 19096288 BACKGROUND

• Ring H, Treger I, Gruendlinger L, Hausdorff JM. Neuroprosthesis for footdrop compared with an ankle-foot orthosis: effects on postural control during walking. J Stroke Cerebrovasc Dis. 2009 Jan;18(1):41-7. doi: 10.1016/j.jstrokecerebrovasdis.2008.08.006.

  PMID: 19110144 BACKGROUND

• Stein RB, Everaert DG, Thompson AK, Chong SL, Whittaker M, Robertson J, Kuether G. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair. 2010 Feb;24(2):152-67. doi: 10.1177/1545968309347681. Epub 2009 Oct 21.

  PMID: 19846759 BACKGROUND

• O'Dell MW, Dunning K, Kluding P, Wu SS, Feld J, Ginosian J, McBride K. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. PM R. 2014 Jul;6(7):587-601; quiz 601. doi: 10.1016/j.pmrj.2014.01.001. Epub 2014 Jan 9.

  PMID: 24412265 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Karen D Ethans, MD

  Health Sciences Centre, Winnipeg

  PRINCIPAL INVESTIGATOR

• Jessie R Shea, MSc

  Health Sciences Centre, Winnipeg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Cord Rehabilitation Program

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 25, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

CA (1)