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

NCT03410498 | Unknown

• 1 other identifier: QueenMU 12.1.2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 3D gait analysis

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

  Baseline

Secondary Outcomes (1)

• Stroop test/3D gait analysis

  Baseline

Study Arms (1)

MS group

OTHER

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

Interventions

Incremental shuttle walk test OTHER

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.

Also known as: Stroop test

MS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Margaret University: lead

Study Sites (1)

Queen Margeret University

Musselburgh, EH21 6UU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Stroop Test

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Thomas H Mercer, Prof.

  Queen Margaret University

  STUDY CHAIR

Central Study Contacts

Georgia Andreopoulou, Msc

CONTACT

07873854432; GAndreopoulou@qmu.ac.uk

Marietta van der Linden, PhD

CONTACT

mvanderlinden@qmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 25, 2018
• Study Start: August 1, 2018
• Primary Completion: December 29, 2024
• Study Completion: December 29, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

GB (1)