Multiple SclerosisNCT02123537
Treating Foot Drop in People With Multiple Sclerosis Using Electrical Stimulation
A study testing Bioness L300 Foot Drop System in people with Multiple Sclerosis and Foot Drop, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Foot Drop
- What is being tested?
- Bioness L300 Foot Drop System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Rehabilitation Hospital, Health Sciences Centre
Winnipeg, Manitoba, R3A 1M4
About this study
Official title: Functional Electrical Stimulation to Treat Foot Drop in People With Multiple Sclerosis
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, Foot Drop
- Being tested
- Bioness L300 Foot Drop System
- Keywords
- Bioness L300 Foot Drop System, Functional electrical stimulation
- Medical subject headings
- Multiple Sclerosis, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioness L300 Foot Drop SystemDevice
Participants will use the Bioness L300 Foot Drop System during waking hours for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bioness L300 Foot Drop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Physiological cost index during walking tests
Based on heart rate, this will assess the physiological cost of walking, as compared to baseline.
Measured: 4 weeks
Physiological cost index during walking tests
Based on heart rate, this will assess the physiological cost of walking, as compared to baseline.
Measured: 8 weeks
Physiological cost index during walking tests
Based on heart rate, this will assess the physiological cost of walking, as compared to baseline.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Riverview Health Centre Foundation
- Responsible party
- Principal investigator, Dr. Karen Ethans, University of Manitoba
- Investigators
- Karen D Ethans, MD, Principal investigator, Health Sciences Centre, WinnipegJessie R Shea, MSc, Study director, Health Sciences Centre, Winnipeg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123537
- Sponsor's protocol ID
- MSFD2014
- Status last verified
- Sep 2016
- First submitted
- 23 Apr 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19096288Ring 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.
PubMed 19110144Stein 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.
PubMed 19846759O'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.
PubMed 24412265
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation to Treat Foot Drop in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02123537
- Acronym / sponsor ID
- MSFD2014
- Conditions
- Multiple Sclerosis, Foot Drop
- Keywords
- Bioness L300 Foot Drop System, Functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Riverview Health Centre Foundation
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioness L300 Foot Drop System | Experimental | Device: Bioness L300 Foot Drop SystemParticipants will use the Bioness L300 Foot Drop System for walking daily during the 12 weeks of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioness L300 Foot Drop SystemParticipants will use the Bioness L300 Foot Drop System during waking hours for 12 weeks. | Device | Bioness L300 Foot Drop System |
Primary outcome
Speed during the 10-metre straight line walking test
Time frame: 12 weeks
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.
10 secondary outcomes
Distance travelled during the 4-minute figure-8 walking test
Time frame: 12 weeks
Speed during the 10-metre straight line walking test
Time frame: 4 weeks
Speed during the 10-metre straight line walking test
Time frame: 8 weeks
Distance travelled during the 4-minute figure-8 walking test
Time frame: 4 weeks
Distance travelled during the 4-minute figure-8 walking test
Time frame: 8 weeks
Physiological cost index during walking tests
Time frame: 4 weeks
Physiological cost index during walking tests
Time frame: 8 weeks
Physiological cost index during walking tests
Time frame: 12 weeks
Participant satisfaction questionnaire score
Time frame: 12 weeks
Treadmill Gait Assessment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 19096288Laufer 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.
- Background: PubMed 19110144Ring 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.
- Background: PubMed 19846759Stein 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.
- Background: PubMed 24412265O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen D Ethans, MD principal investigator
Health Sciences Centre, Winnipeg
Jessie R Shea, MSc study director
Health Sciences Centre, Winnipeg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioness L300 Foot Drop System in people with Multiple Sclerosis and Foot Drop, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed during the 10-metre straight line walking test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123537, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.