Clinical trial NCT03410498: The Effects of FES in a Variety of Walking Conditions in People With MS
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: 3D gait analysis
timeFrame: Baseline
Secondary outcomes:
measure: Stroop test/3D gait analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen Margeret University
Study officials:
affiliation: Queen Margaret University
name: Thomas H Mercer, Prof.
role: STUDY_CHAIR
References: