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

November 15, 2023 updated by: Georgia Andreopoulou, Queen Margaret University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MS group
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.
Other: Incremental shuttle walk 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.

Other Names:
  • Stroop test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D gait analysis
Time Frame: Baseline
The orthotic effect, i.e. the difference in ankle angle with the FES on and off.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroop test/3D gait analysis
Time Frame: Baseline
Dual task cost of walking speed
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Margaret University

Investigators

  • Study Chair: Thomas H Mercer, Prof., Queen Margaret University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Estimated)

December 29, 2024

Study Completion (Estimated)

December 29, 2024

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QueenMU 12.1.2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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