An interventional study of Bioness L300 Foot Drop System in Multiple Sclerosis and Foot Drop, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
Due to damage of their central nervous system, people with multiple sclerosis (MS) often develop abnormal gait. One common problem is the inability to lift the foot during the swing phase; this is called foot drop, and is caused by loss of ankle dorsiflexor strength and spasticity of the ankle plantarflexors. Foot drop leads to imbalance and increased risk of falling, due to the foot dragging on the ground. Treating foot drop can result in improved gait, faster walking speeds, improved balance and reduced risk of falling.
Functional electrical stimulation (FES) stimulates either the superficial or deep branches of the common peroneal nerve. This stimulation leads to contraction of the ankle dorsiflexors and evertors, which causes dorsiflexion and eversion of the foot, resulting in the stepping motion of lifting the toes toward the shin. This reduces foot drop, allowing the user to regain a more natural stepping pattern; it also reduces spasticity, strengthens muscles and increases joint range of motion.
The Bioness L300 Foot Drop System consists of three components: a leg cuff worn just below the knee, which provides electrical stimulation to the common peroneal nerve; a gait sensor attached to the shoe, which detects which stage of the gait cycle the foot is in; and a control unit, which is used to adjust the level of stimulation received. These three components communicate wirelessly with each other, so that the electrical stimulation is applied at the appropriate time during each gait cycle.
The study physician will set up the system to optimize stimulation according to each participant's gait and needs, and participants will use the system for 12 weeks. There will be an initial four week adaptation period for using the system. During this first four weeks participants will gradually increase their use of the system until they are using it all day, which will allow their muscles to adjust to the electrical stimulation and help prevent fatigue. During the remaining eight weeks participants will be instructed to use the system all day, when walking at home and in the community.
Participants will have their walking speed and heart rate measured during a 10-metre straight line walking test and a 4-minute figure-8 walking test at baseline, weeks 4, 8 and 12. Participants will perform both tests at each time point without and with the L300 Foot Drop System. Participant satisfaction will be assessed at the end of the 12-week trial.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants will use the Bioness L300 Foot Drop System during waking hours for 12 weeks.
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.
Time frame: 12 weeks
Distance travelled during the 4-minute figure-8 walking test
During the 4-minute figure-8 walking test, participants walk at a self-selected speed around a figure-8 track as many times as they can during the four-minute test. The test measures speed, balance, stability and coordination, since it incorporates turning.
Time frame: 12 weeks
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. This timepoint will assess the initial effects of the L300 device.
Time frame: 4 weeks
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.
Time frame: 8 weeks
Distance travelled during the 4-minute figure-8 walking test
During the 4-minute figure-8 walking test, participants walk at a self-selected speed around a figure-8 track as many times as they can during the four-minute test. The test measures speed, balance, stability and coordination, since it incorporates turning. This timepoint will assess the initial effects of the L300 device.
Time frame: 4 weeks
Distance travelled during the 4-minute figure-8 walking test
During the 4-minute figure-8 walking test, participants walk at a self-selected speed around a figure-8 track as many times as they can during the four-minute test. The test measures speed, balance, stability and coordination, since it incorporates turning.
Time frame: 8 weeks
Physiological cost index during walking tests
Based on heart rate, this will assess the physiological cost of walking, as compared to baseline.
Time frame: 4 weeks
Physiological cost index during walking tests
Based on heart rate, this will assess the physiological cost of walking, as compared to baseline.
Time frame: 8 weeks
Physiological cost index during walking tests
Based on heart rate, this will assess the physiological cost of walking, as compared to baseline.
Time frame: 12 weeks
Participant satisfaction questionnaire score
The satisfaction questionnaire will assess participant satisfaction with the L300 Foot Drop System. It will include information about ease of use and desire to continue using the system.
Time frame: 12 weeks
Treadmill Gait Assessment
Participants will walk on a standard treadmill at a slow, comfortable speed between 0.5 to 0.8 m/s for one minute. The treadmill is instrumented with an unobtrusive pressure mapping system (Vista Medical Ltd) under the treadmill belt. The pressure mapping system records the centre of foot pressure for each step, which is used to compute step length and width, step time and swing time for 30 consecutive steps. These spatio-temporal gait variables are used to quantify gait performance. This assessment will be completed at baseline and week 12.
Time frame: 12 weeks
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Manitoba