Multiple SclerosisNCT01977287
Walking With FES or AFO in People With MS With Foot Drop
An observational study of Multiple Sclerosis and Foot Drop, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
This investigation consists of two parallel groups of participants who will follow the same protocol. The aim of the study is to investigate the effects of using Functional Electrical Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12 week period in people with MS who experience… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Foot Drop
- What is being tested?
- Functional Electrical Stimulation and Ankle Foot Orthosis
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Mar 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Multiple Sclerosis who have been prescribed either FES or an AFO to treat foot drop by their physiotherapist.
Who may be able to join
- People diagnosed with Multiple Sclerosis
- Prescribed either AFO or FES to treat drop foot by their physiotherapist
- aged 18-75
Who cannot join
- Unable to walk 10 meters
- Bilateral device use
- Breastfeeding or pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University
Musselburgh, East Lothian, EH21 6UU
About this study
Official title: A Pilot Study to Assess the Effects of Using FES or AFO as an Assistive Mobility for Period of 12 Weeks for People With Multiple Sclerosis With Foot Drop
This investigation consists of two parallel groups of participants who will follow the same protocol. The aim of the study is to investigate the effects of using Functional Electrical Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12 week period in people with MS who experience foot drop. Patients who are clinically prescribed FES will be invited to participate in the FES arm of the study. Patients who are clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6 weeks and 12 weeks of device use. Participants' walking will assessed using computerised three dimensional motion analysis, which will provide a detailed description of the movements (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk and a two minute walk. Both gait analysis and the walking performance tests will be carried out with and without an assistive device; apart from their first session where participants will only be assessed without their assistive device.
Participants will be asked to wear an activity monitor for 7 days after each assessment. In addition participants will be asked to complete four short standardised questionnaires (MS walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of life score) at each assessment.
- Conditions
- Multiple Sclerosis, Foot Drop
- Being tested
- Functional Electrical Stimulation, Ankle Foot Orthosis
- Keywords
- Multiple Sclerosis, Functional Electrical Stimulation, Ankle Foot Orthosis, Walking performance, gait analysis, fatigue, activity monitoring
- Medical subject headings
- Multiple Sclerosis, Peroneal Neuropathies, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
Also called Odstock Dropped Foot Stimulator (ODFS) III, ODFS Pace
Ankle Foot OrthosisDevice
Also called splint
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation | The Functional Electrical Stimulation (FES) group will be asked to use their clinically prescribed FES unit (either ODFS III or Pace) to the dorsiflexors to treat foot drop for a period of 12 weeks. Receives: Device: Functional Electrical Stimulation | |
| Ankle Foot Orthosis | The people in the Ankle Foot Orthosis group (AFO) will be asked to use their clinically prescribed AFO to treat drop foot for a period of 12 weeks. Receives: Device: Ankle Foot Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time taken for 10 meter walk test
In the 10 meter walk test, the time taken by the participant to walk 10 meters is recorded. The test is repeated and the average is taken for analysis.
Measured: change from baseline in 10m walk test at 12 weeks
Secondary outcomes (1)
Change in ankle dorsiflexion angle at initial contact
The ankle dorsiflexion angle is derived from gait analysis. The angle of the ankle at the time the foot contacts the floor during a step is derived. This is repeated for at least 5 different walks, and the average of those 5 walks is calculated for further analysis.
Measured: The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJun 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society UK, 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
- NCT01977287
- Sponsor's protocol ID
- FESvsAFO2013
- Status last verified
- Apr 2016
- First submitted
- 30 Oct 2013
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Linden ML, Hooper JE, Cowan P, Weller BB, Mercer TH. Habitual functional electrical stimulation therapy improves gait kinematics and walking performance, but not patient-reported functional outcomes, of people with multiple sclerosis who present with foot-drop. PLoS One. 2014 Aug 18;9(8):e103368. doi: 10.1371/journal.pone.0103368. eCollection 2014.
PubMed 25133535
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effects of Using FES or AFO as an Assistive Mobility for Period of 12 Weeks for People With Multiple Sclerosis With Foot Drop
- ClinicalTrials.gov ID
- NCT01977287
- Acronym / sponsor ID
- FESvsAFO2013
- Conditions
- Multiple Sclerosis, Foot Drop
- Keywords
- Multiple Sclerosis, Functional Electrical Stimulation, Ankle Foot Orthosis, Walking performance, gait analysis, fatigue, activity monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society UK, NHS Lothian
- Study start
- Jun 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Nov 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.
This investigation consists of two parallel groups of participants who will follow the same protocol. The aim of the study is to investigate the effects of using Functional Electrical Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12 week period in people with MS who experience foot drop. Patients who are clinically prescribed FES will be invited to participate in the FES arm of the study. Patients who are clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6 weeks and 12 weeks of device use. Participants' walking will assessed using computerised three dimensional motion analysis, which will provide a detailed description of the movements (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk and a two minute walk. Both gait analysis and the walking performance tests will be carried out with and without an assistive device; apart from their first session where participants will only be assessed without their assistive device.
Participants will be asked to wear an activity monitor for 7 days after each assessment. In addition participants will be asked to complete four short standardised questionnaires (MS walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of life score) at each assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation | – | Device: Functional Electrical StimulationThe Functional Electrical Stimulation (FES) group will be asked to use their clinically prescribed FES unit (either ODFS III or Pace) to the dorsiflexors to treat foot drop for a period of 12 weeks. |
| Ankle Foot Orthosis | – | Device: Ankle Foot OrthosisThe people in the Ankle Foot Orthosis group (AFO) will be asked to use their clinically prescribed AFO to treat drop foot for a period of 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Multiple Sclerosis who have been prescribed either FES or an AFO to treat foot drop by their physiotherapist.
Key inclusion criteria (3 listed)
- People diagnosed with Multiple Sclerosis
- Prescribed either AFO or FES to treat drop foot by their physiotherapist
- aged 18-75
Key exclusion criteria (3 listed)
- Unable to walk 10 meters
- Bilateral device use
- Breastfeeding or pregnant
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 |
|---|---|---|
| Functional Electrical StimulationAlso: Odstock Dropped Foot Stimulator (ODFS) III, ODFS Pace | Device | Functional Electrical Stimulation |
| Ankle Foot OrthosisAlso: splint | Device | Ankle Foot Orthosis |
Primary outcome
Change in time taken for 10 meter walk test
Time frame: change from baseline in 10m walk test at 12 weeks
In the 10 meter walk test, the time taken by the participant to walk 10 meters is recorded. The test is repeated and the average is taken for analysis.
1 secondary outcome
Change in ankle dorsiflexion angle at initial contact
Time frame: The change from baseline of the ankle dorsiflexion angle at initial contact from at 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 4 Apr 2016.
- Derived from this study: PubMed 25133535van der Linden ML, Hooper JE, Cowan P, Weller BB, Mercer TH. Habitual functional electrical stimulation therapy improves gait kinematics and walking performance, but not patient-reported functional outcomes, of people with multiple sclerosis who present with foot-drop. PLoS One. 2014 Aug 18;9(8):e103368. doi: 10.1371/journal.pone.0103368. eCollection 2014.
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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?
An observational study of Multiple Sclerosis and Foot Drop, 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 3 inclusion and 3 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 Apr 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?
Change in time taken for 10 meter walk test (time frame: change from baseline in 10m walk test at 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 NCT01977287, which also lists 1 linked publication.
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 Apr 2016.