Multiple SclerosisNCT01914016
Functional Electrical Stimulation for People With Multiple Sclerosis Who Experience Foot Drop
A study testing prolonged walk in people with Multiple Sclerosis, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
People with Multiple Sclerosis (pwMS) often experience 'foot-drop' which means that the foot is not adequately lifted during the so-called swing phase (foot is off the ground) during walking which can lead to trips and falls. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- prolonged walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Nov 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with MS (aged 18-80) who are assessed for their suitability for FES to treat foot-drop between September 2013 and March 2014 at Slateford Medical Centre are eligible for participation in this study
Who cannot join
- Patients with fixed ankle deformities, who are allergic to tape and who are unable to walk for at least for two minutes (with or without walking aids) will be excluded.
- Patients who experienced a relapse or any trauma affecting their walking between the first fitting appointment and the follow-up appointment will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Electrical Stimulation for People With Multiple Sclerosis Who Experience Foot Drop:Feasibility of Instrumented Gait Analysis in Clinical Practice.
People with Multiple Sclerosis (pwMS) often experience 'foot-drop' which means that the foot is not adequately lifted during the so-called swing phase (foot is off the ground) during walking which can lead to trips and falls. Functional Electrical Stimulation (FES) to the shin muscles will aid lifting of the foot and therefore reduces the risk of trips and falls. There have been several studies showing the benefits of FES to the walking of pwMS. The proposed study aims to optimise the FES prescription and fitting care pathway for pwMS in Edinburgh and the Lothians This will be achieved firstly through a survey to all clients with MS in the last 5 years who have been regarded as suitable for FES. Secondly, a pilot study will assess the suitability of the use of simple clinical measurement (electrogoniometry) which will allow the measurement of the degree of foot-drop. The degree is foot drop is usually assessed by the physiotherapist using visual observation. Using a small device which can be quickly fitted to the patient's lower and foot for the duration of a 2-6 minute walk, the physiotherapist will be able to quantify the degree of foot drop over time. Such a measurement is especially important for people with MS who are often affected by increased mental and physical fatigue.
Our first hypothesis is that the degree of foot-drop at the end of the walk is increased compared to the start of the walk. Secondly, we hypothesise that the degree of foot drop is less when the participant walks with the assistance of Functional Electrical Stimulation at their next clinical appointment.
Read the detailed description
Participants People with MS (aged 18 or over) who are assessed for their suitability for FES to treat foot-drop at Slateford Medical Centre are eligible for participation in this study.
For this feasibility study we aim to recruit at least 10 participants.
Recruitment Eligible patients will be given an information sheet by their physiotherapist who will introduce the study at their initial appointment. A second appointment is made to fit the FES unit and if the patient is willing to consider taking part in the study, informed consent is taken.
Data collection To record the degree of foot-drop, one arm of the electrogoniometer will be attached to the side of the participant's lower leg and the other arm to the shoe using skin-friendly double sided adhesive tape.
The participant will then be asked to walk in their normal walking speed around the corridors of the clinic for six minutes or shorter if the participant is not able to walk for this duration. A data logger carried on the belt on the participant's waist will continuously record the ankle angle data at 50Hz. Walking speed will be derived by measuring the distance walked in the time recorded. Rate of perceived exertion on the Borg Scale will be recorded every minute and immediately after the walk. Participants will also be asked to fill in a questionnaire on their perceived walking performance (Multiple Sclerosis Walking Scale 12).
At a follow-up appointment (1-2 weeks later) this data collection will be repeated with the participant using the FES unit.
Data analysis. To assess the impact of fatigue on the ankle angle during prolonged walking, ankle angle data in the first and last 60 seconds of the walk will be recorded. Two way ANOVA will be employed to analyse both the effects of time (within session) and that of FES use ('Off' and 'On', between sessions) on the degree of foot-drop if data are normally distributed. Equivalent non-parametric statistics will be used for non normally distributed data. Statistical significance will be accepted at p<0.05.
Inclusion criteria People with MS (aged 18-80) who are assessed for their suitability for FES to treat foot-drop between September 2013 and March 2014 at Slateford Medical Centre are eligible for participation in this study.
Exclusion criteria Patients with fixed ankle deformities, who are allergic to tape and who are unable to walk for at least for two minutes (with or without walking aids) will be excluded. Patients who experienced a relapse or any trauma affecting their walking between the first fitting appointment and the follow-up appointment will also be excluded from the study.
- Conditions
- Multiple Sclerosis
- Being tested
- prolonged walk
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged walkOther
Participants will be asked to walk for a duration of between 2 -6 minutes until they rate their perceived exertion as 'Hard' (RPE 16 on Borg Scale)
| Study group | Role | What they receive |
|---|---|---|
| prolonged walk | Other | Not described Receives: Other: prolonged walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak dorsiflexion angle during the swing phase without FES
The electrogoniometer record the (sagittal) ankle angle during the 2-6 minute walk around the physiotherapy department. In the data processing stage, the peak dorsiflexion angle during the swing phase will be determined for each gait cycle over a period of 20 seconds at the start and at the end of the walk.
Measured: Baseline
Secondary outcomes (3)
Rate of perceived exertion (RPE)
The participant will be asked to rate his/her perceived exertion on the Borg Scale (6-20) at minute intervals during the walk.
Measured: Baseline
Peak dorsiflexion angle during swing phase (with FES)
The electrogoniometer record the (sagittal) ankle angle during the 2-6 minute walk around the physiotherapy department. In the data processing stage, the peak dorsiflexion angle during the swing phase will be determined for each gait cycle over a period of 20 seconds at the start and at the end of the walk.
Measured: two weeks from baseline
Rates of perceived Exertion (RPE) with FES
The participant will be asked to rate his/her perceived exertion on the Borg Scale (6-20) at minute intervals during the walk
Measured: 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Principal investigator, Marietta van der Linden, Queen Margaret University
- Investigators
- Marietta L van der Linden, PhD, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914016
- Sponsor's protocol ID
- QMU ELHF109-121
- Status last verified
- Sep 2016
- First submitted
- 25 Jun 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation for People With Multiple Sclerosis Who Experience Foot Drop:Feasibility of Instrumented Gait Analysis in Clinical Practice.
- ClinicalTrials.gov ID
- NCT01914016
- Acronym / sponsor ID
- QMU ELHF109-121
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Aug 2013 (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 (pwMS) often experience 'foot-drop' which means that the foot is not adequately lifted during the so-called swing phase (foot is off the ground) during walking which can lead to trips and falls. Functional Electrical Stimulation (FES) to the shin muscles will aid lifting of the foot and therefore reduces the risk of trips and falls. There have been several studies showing the benefits of FES to the walking of pwMS. The proposed study aims to optimise the FES prescription and fitting care pathway for pwMS in Edinburgh and the Lothians This will be achieved firstly through a survey to all clients with MS in the last 5 years who have been regarded as suitable for FES. Secondly, a pilot study will assess the suitability of the use of simple clinical measurement (electrogoniometry) which will allow the measurement of the degree of foot-drop. The degree is foot drop is usually assessed by the physiotherapist using visual observation. Using a small device which can be quickly fitted to the patient's lower and foot for the duration of a 2-6 minute walk, the physiotherapist will be able to quantify the degree of foot drop over time. Such a measurement is especially important for people with MS who are often affected by increased mental and physical fatigue.
Our first hypothesis is that the degree of foot-drop at the end of the walk is increased compared to the start of the walk. Secondly, we hypothesise that the degree of foot drop is less when the participant walks with the assistance of Functional Electrical Stimulation at their next clinical appointment.
Detailed description
Participants People with MS (aged 18 or over) who are assessed for their suitability for FES to treat foot-drop at Slateford Medical Centre are eligible for participation in this study.
For this feasibility study we aim to recruit at least 10 participants.
Recruitment Eligible patients will be given an information sheet by their physiotherapist who will introduce the study at their initial appointment. A second appointment is made to fit the FES unit and if the patient is willing to consider taking part in the study, informed consent is taken.
Data collection To record the degree of foot-drop, one arm of the electrogoniometer will be attached to the side of the participant's lower leg and the other arm to the shoe using skin-friendly double sided adhesive tape.
The participant will then be asked to walk in their normal walking speed around the corridors of the clinic for six minutes or shorter if the participant is not able to walk for this duration. A data logger carried on the belt on the participant's waist will continuously record the ankle angle data at 50Hz. Walking speed will be derived by measuring the distance walked in the time recorded. Rate of perceived exertion on the Borg Scale will be recorded every minute and immediately after the walk. Participants will also be asked to fill in a questionnaire on their perceived walking performance (Multiple Sclerosis Walking Scale 12).
At a follow-up appointment (1-2 weeks later) this data collection will be repeated with the participant using the FES unit.
Data analysis. To assess the impact of fatigue on the ankle angle during prolonged walking, ankle angle data in the first and last 60 seconds of the walk will be recorded. Two way ANOVA will be employed to analyse both the effects of time (within session) and that of FES use ('Off' and 'On', between sessions) on the degree of foot-drop if data are normally distributed. Equivalent non-parametric statistics will be used for non normally distributed data. Statistical significance will be accepted at p<0.05.
Inclusion criteria People with MS (aged 18-80) who are assessed for their suitability for FES to treat foot-drop between September 2013 and March 2014 at Slateford Medical Centre are eligible for participation in this study.
Exclusion criteria Patients with fixed ankle deformities, who are allergic to tape and who are unable to walk for at least for two minutes (with or without walking aids) will be excluded. Patients who experienced a relapse or any trauma affecting their walking between the first fitting appointment and the follow-up appointment will also be excluded from the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prolonged walk | Other | Other: prolonged walk |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People with MS (aged 18-80) who are assessed for their suitability for FES to treat foot-drop between September 2013 and March 2014 at Slateford Medical Centre are eligible for participation in this study
Key exclusion criteria (2 listed)
- Patients with fixed ankle deformities, who are allergic to tape and who are unable to walk for at least for two minutes (with or without walking aids) will be excluded.
- Patients who experienced a relapse or any trauma affecting their walking between the first fitting appointment and the follow-up appointment will also be excluded from the study.
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 |
|---|---|---|
| prolonged walkParticipants will be asked to walk for a duration of between 2 -6 minutes until they rate their perceived exertion as 'Hard' (RPE 16 on Borg Scale) | Other | prolonged walk |
Primary outcome
Peak dorsiflexion angle during the swing phase without FES
Time frame: Baseline
The electrogoniometer record the (sagittal) ankle angle during the 2-6 minute walk around the physiotherapy department. In the data processing stage, the peak dorsiflexion angle during the swing phase will be determined for each gait cycle over a period of 20 seconds at the start and at the end of the walk.
3 secondary outcomes
Rate of perceived exertion (RPE)
Time frame: Baseline
Peak dorsiflexion angle during swing phase (with FES)
Time frame: two weeks from baseline
Rates of perceived Exertion (RPE) with FES
Time frame: 2 weeks from baseline
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 28 Sep 2016.
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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.
Marietta L van der Linden, PhD principal investigator
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolonged walk in people with Multiple Sclerosis, run by Queen Margaret University at 1 site in United Kingdom.
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 1 inclusion and 2 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 28 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 United Kingdom. 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?
Peak dorsiflexion angle during the swing phase without FES (time frame: Baseline). 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 28 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.