The Effects of FES in a Variety of Walking Conditions in People With MS

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: Incremental shuttle walk test

• Registration Number: NCT03410498
• Lead Sponsor: Queen Margaret University

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.

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-25
• Study Start: 2018-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12-29
• Study Completion: 2024-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MS group	Incremental shuttle walk test	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.

Primary Outcome Measures

Name	Time	Method
3D gait analysis	Baseline	The orthotic effect, i.e. the difference in ankle angle with the FES on and off.

Secondary Outcome Measures

Name	Time	Method
Stroop test/3D gait analysis	Baseline	Dual task cost of walking speed

Trial Locations

Locations (1)

Queen Margeret University; 🇬🇧 Musselburgh, United Kingdom