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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Incremental shuttle walk test
Sponsored by
Queen Margaret University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Queen Margeret UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MS group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stroop test/3D gait analysis
Dual task cost of walking speed

Full Information

First Posted
January 17, 2018
Last Updated
September 9, 2021
Sponsor
Queen Margaret University
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1. Study Identification

Unique Protocol Identification Number
NCT03410498
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 29, 2022 (Anticipated)
Study Completion Date
December 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Margaret University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MS group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Incremental shuttle walk test
Other Intervention Name(s)
Stroop test
Intervention Description
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.
Primary Outcome Measure Information:
Title
3D gait analysis
Description
The orthotic effect, i.e. the difference in ankle angle with the FES on and off.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Stroop test/3D gait analysis
Description
Dual task cost of walking speed
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgia Andreopoulou, Msc
Phone
07873854432
Email
GAndreopoulou@qmu.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Marietta van der Linden, PhD
Email
mvanderlinden@qmu.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Mercer, Prof.
Organizational Affiliation
Queen Margaret University
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Margeret University
City
Musselburgh
ZIP/Postal Code
EH21 6UU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Andreopoulou, Msc
Email
GAndreopoulou@qmu.ac.uk

12. IPD Sharing Statement

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

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