Gait Disorders, NeurologicNCT03300986
Parameter Changes in Functional Electrical Stimulation
An observational study of Gait Disorders, Neurologic, run by The Leeds Teaching Hospitals NHS Trust.
Trial summary
This study aims to look at how changes to a person's functional electrical stimulation might change how they walk. Functional electrical stimulation (FES) is commonly used to help people with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gait Disorders, Neurologic
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 2 May 2017
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population for this study is adult users of standard FES for foot drop, registered with the Leeds FES service. Any upper motor neurone lesion can be the primary condition.
Who may be able to join
- Upper motor neurone lesion causing foot drop
- Currently use single-channel Odstock Medical ODFS functional electrical stimulator
- Age 18 or older
- Attending Leeds FES Service follow-up clinics
Who cannot join
- • FES user for less than three months
- Lower limb prosthesis
- Cannot walk 5m with walking aids
- Cannot walk twenty 5m walks within a three-hour period
- Use FES less than once per week
About this study
This study aims to look at how changes to a person's functional electrical stimulation might change how they walk. Functional electrical stimulation (FES) is commonly used to help people with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This group of people have muscle weakness which makes it difficult to lift the foot, which causes trips and falls.
FES reduces foot drop by using a portable device to apply short electrical pulses to the nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase, when the foot is off the floor. Typically this is achieved by using a foot-switch, which detects when the heel leaves the floor. Stimulation begins a short interval of time after the heel leaves the floor, ramps up from zero to set stimulation for the individual, and at another period of time after the heel hits the floor, stimulation ramps down from set amount to zero. There are four time intervals described here which can be varied by the clinician on the device:-
- Delay (the time between heel lift and the start of stimulation)
- Ramp up (the time for stimulation to reach full strength)
- Extension (the time between heel strike and the ramp down)
- Ramp down (the time for stimulation to reach zero from full strength) These intervals are usually set by experienced clinicians using a qualitative assessment of the patient's walking and trial-and-error. A literature review has found no published studies which compare walking with different timing. This knowledge would be useful for clinicians, who could use this information as a starting point in finding the best timing parameters for each patient.
- Conditions
- Gait Disorders, Neurologic
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation (FES) users | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis will be measured according to routine protocol
Gait analysis will measured in accordance with the Plug-In-Gait model guide. This measures 16 points on the subjects left and right leg.
Measured: Gait will be assessed over one visit of three hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Apr 2016
- Primary completionMar 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300986
- Sponsor's protocol ID
- MP16/017
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameter Changes in Functional Electrical Stimulation
- ClinicalTrials.gov ID
- NCT03300986
- Acronym / sponsor ID
- MP16/017
- Conditions
- Gait Disorders, Neurologic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 4 Oct 2017 (actual)
- 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.
This study aims to look at how changes to a person's functional electrical stimulation might change how they walk. Functional electrical stimulation (FES) is commonly used to help people with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This group of people have muscle weakness which makes it difficult to lift the foot, which causes trips and falls.
FES reduces foot drop by using a portable device to apply short electrical pulses to the nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase, when the foot is off the floor. Typically this is achieved by using a foot-switch, which detects when the heel leaves the floor. Stimulation begins a short interval of time after the heel leaves the floor, ramps up from zero to set stimulation for the individual, and at another period of time after the heel hits the floor, stimulation ramps down from set amount to zero. There are four time intervals described here which can be varied by the clinician on the device:-
- Delay (the time between heel lift and the start of stimulation)
- Ramp up (the time for stimulation to reach full strength)
- Extension (the time between heel strike and the ramp down)
- Ramp down (the time for stimulation to reach zero from full strength) These intervals are usually set by experienced clinicians using a qualitative assessment of the patient's walking and trial-and-error. A literature review has found no published studies which compare walking with different timing. This knowledge would be useful for clinicians, who could use this information as a starting point in finding the best timing parameters for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation (FES) users | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population for this study is adult users of standard FES for foot drop, registered with the Leeds FES service. Any upper motor neurone lesion can be the primary condition.
Key inclusion criteria (4 listed)
- Upper motor neurone lesion causing foot drop
- Currently use single-channel Odstock Medical ODFS functional electrical stimulator
- Age 18 or older
- Attending Leeds FES Service follow-up clinics
Key exclusion criteria (5 listed)
- • FES user for less than three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait analysis will be measured according to routine protocol
Time frame: Gait will be assessed over one visit of three hours.
Gait analysis will measured in accordance with the Plug-In-Gait model guide. This measures 16 points on the subjects left and right leg.
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 4 Oct 2017.
Related trials for Gait Disorders, Neurologic
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Not yet recruiting
Effects of Jaw Clenching on Gait and Mobility in Stroke
Stroke
Active, not recruiting
Comparative Effects of Vestibular Rehabilitation With and Without Cervical JPS Training in Stroke Patients
Stroke
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Recruiting
Interactive Intensive Gait Training in Walking Limitations
Neurologic Ambulation Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Disorders, Neurologic, run by The Leeds Teaching Hospitals NHS Trust.
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 4 inclusion and 5 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Gait analysis will be measured according to routine protocol (time frame: Gait will be assessed over one visit of three hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2017.