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Clinical Trials/NCT03410498
NCT03410498
Recruiting
Not Applicable

The Orthotic Effect of Functional Electrical Stimulation to Treat Foot Drop in People With MS Under Walking Conditions Simulating Those in Daily Life

Queen Margaret University1 site in 1 country20 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Queen Margaret University
Enrollment
20
Locations
1
Primary Endpoint
3D gait analysis
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
December 29, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Georgia Andreopoulou

Principal Investigator

Queen Margaret University

Eligibility Criteria

Inclusion Criteria

  • For people with MS:
  • Clinically definite multiple sclerosis according to the revised McDonald criteria.
  • People with EDSS ≤ 5.
  • 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) ≤
  • Depression and anxiety; with a score in Hospital Anxiety \& Depression Scale (HADS) \> 10.

Outcomes

Primary Outcomes

3D gait analysis

Time Frame: Baseline

The orthotic effect, i.e. the difference in ankle angle with the FES on and off.

Secondary Outcomes

  • Stroop test/3D gait analysis(Baseline)

Study Sites (1)

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