Multiple SclerosisNCT03410498
The Effects of FES in a Variety of Walking Conditions in People With MS
A study testing Incremental shuttle walk test in people with Multiple Sclerosis, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
The aim of this study is to measure the difference in the walking performance when functional electrical stimulation (FES) is on and off in people with MS that present foot drop under different 'real life' conditions, i.e. walking while doing another task that requires your attention and after been physically tired Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Incremental shuttle walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2018to 29 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For people with MS:
- Clinically definite multiple sclerosis according to the revised McDonald criteria.
- People with EDSS ≤ 5.0.
- People with MS who experience foot drop.
- Able to walk at least 200 meters unassisted, i.e without walking aids.
- For healthy participants:
- Not been diagnosed with any neurological disease or have any other condition or injury which will affect walking ability.
Who cannot join
- For people with MS:
- Clinically diagnosed relapse within the last month.
- Any musculoskeletal impairment that can affect walking ability.
- Cognitive impairments; with a score in the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) ≤ 75.
- Depression and anxiety; with a score in Hospital Anxiety \& Depression Scale (HADS) > 10.
Trial locations and contacts
1 site in 1 country.
Marietta van der Linden, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Margeret University
Musselburgh, EH21 6UU
Georgia Andreopoulou, Msc, GAndreopoulou@qmu.ac.uk
About this study
Official title: The Orthotic Effect of Functional Electrical Stimulation to Treat Foot Drop in People With MS Under Walking Conditions Simulating Those in Daily Life
The aim of this study is to measure the difference in the walking performance when functional electrical stimulation (FES) is on and off in people with MS that present foot drop under different 'real life' conditions, i.e. walking while doing another task that requires your attention and after been physically tired
Read the detailed description
People with Multiple Sclerosis (pwMS) often experience foot drop, which means that the foot is not adequately lifted from the ground when walking. Functional Electrical Stimulation (FES) is applied to the shin muscles to aid lifting the foot of the ground and reduces the risk of trips and falls. PwMS that are users of functional electrical stimulation (FES) report that one of the benefits is that it reduces the mental effort of walking and that as a result less concentration is needed when they walk. Motor fatigability, which is the reduced ability of the muscles to produce force or power, also negatively affects the walking performance of pwMS. There have been several studies showing the benefits of FES to the walking of pwMS, but not while performing two tasks at the same time and experiencing fatigability resembling more daily life conditions. The proposed study aims to investigate the direct orthotic effect of FES (FES on vs off) in three different conditions, which include just walking, walking while performing an attention-demanding task and walking with an attention-demanding task after having completed a fatiguing task. The study design of this research allows the quantification of benefits of the use of FES which have until now only be reported subjectively.
- Conditions
- Multiple Sclerosis
- Being tested
- Incremental shuttle walk test
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental shuttle walk testOther
Also called Stroop test
In the incremental shuttle walk test, participants will have to walk between two cones (10m distance) several times. The time they will have to cover the distance between the two cones (signified by 'bleeps') will become increasingly shorter, until they cannot get to the next cone before the next 'bleep'. This test will last a maximum of 20 minutes.
In the Stroop test, the words of four colours, but written with a different colour, will be projected on the wall in front of participants and they will need to identify the colour of the text and ignore the word itself.
| Study group | Role | What they receive |
|---|---|---|
| MS group | Other | This group will perform walking trials in various conditions, i.e. normal walking, walking whilst performing an attention demanding task and walking while being physically tired. Receives: Other: Incremental shuttle walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D gait analysis
The orthotic effect, i.e. the difference in ankle angle with the FES on and off.
Measured: Baseline
Secondary outcomes (1)
Stroop test/3D gait analysis
Dual task cost of walking speed
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Aug 2018
- Primary completion29 Dec 2024 (estimated)
- Study completion29 Dec 2024 (estimated)
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Andreopoulou, Queen Margaret University
- Investigators
- Thomas H Mercer, Prof., Study chair, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410498
- Sponsor's protocol ID
- QueenMU 12.1.2018
- Status last verified
- Nov 2023
- First submitted
- 17 Jan 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Orthotic Effect of Functional Electrical Stimulation to Treat Foot Drop in People With MS Under Walking Conditions Simulating Those in Daily Life
- ClinicalTrials.gov ID
- NCT03410498
- Acronym / sponsor ID
- QueenMU 12.1.2018
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 29 Dec 2024 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 25 Jan 2018 (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.
The aim of this study is to measure the difference in the walking performance when functional electrical stimulation (FES) is on and off in people with MS that present foot drop under different 'real life' conditions, i.e. walking while doing another task that requires your attention and after been physically tired
Detailed description
People with Multiple Sclerosis (pwMS) often experience foot drop, which means that the foot is not adequately lifted from the ground when walking. Functional Electrical Stimulation (FES) is applied to the shin muscles to aid lifting the foot of the ground and reduces the risk of trips and falls. PwMS that are users of functional electrical stimulation (FES) report that one of the benefits is that it reduces the mental effort of walking and that as a result less concentration is needed when they walk. Motor fatigability, which is the reduced ability of the muscles to produce force or power, also negatively affects the walking performance of pwMS. There have been several studies showing the benefits of FES to the walking of pwMS, but not while performing two tasks at the same time and experiencing fatigability resembling more daily life conditions. The proposed study aims to investigate the direct orthotic effect of FES (FES on vs off) in three different conditions, which include just walking, walking while performing an attention-demanding task and walking with an attention-demanding task after having completed a fatiguing task. The study design of this research allows the quantification of benefits of the use of FES which have until now only be reported subjectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS group | Other | Other: Incremental shuttle walk testThis group will perform walking trials in various conditions, i.e. normal walking, walking whilst performing an attention demanding task and walking while being physically tired. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinically definite multiple sclerosis according to the revised McDonald criteria.
- People with EDSS ≤ 5.0.
- People with MS who experience foot drop.
- Able to walk at least 200 meters unassisted, i.e without walking aids.
- Not been diagnosed with any neurological disease or have any other condition or injury which will affect walking ability.
Key exclusion criteria (5 listed)
- Clinically diagnosed relapse within the last month.
- Any musculoskeletal impairment that can affect walking ability.
- Cognitive impairments; with a score in the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) ≤ 75.
- Depression and anxiety; with a score in Hospital Anxiety \& Depression Scale (HADS) > 10.
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 |
|---|---|---|
| Incremental shuttle walk testAlso: Stroop testIn the incremental shuttle walk test, participants will have to walk between two cones (10m distance) several times. The time they will have to cover the distance between the two cones (signified by 'bleeps') will become increasingly shorter, until they cannot get to the next cone before the next 'bleep'. This test will last a maximum of 20 minutes. In the Stroop test, the words of four colours, but written with a different colour, will be projected on the wall in front of participants and they will need to identify the colour of the text and ignore the word itself. | Other | MS group |
Primary outcome
3D gait analysis
Time frame: Baseline
The orthotic effect, i.e. the difference in ankle angle with the FES on and off.
1 secondary outcome
Stroop test/3D gait analysis
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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 van der Linden, PhD contact
Thomas H Mercer, Prof. study chair
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 Incremental shuttle walk test 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 7 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgia Andreopoulou, Msc (07873854432, GAndreopoulou@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D gait analysis (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 18 Nov 2023.