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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03410498
• Other study ID #: QueenMU 12.1.2018
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 29, 2024

Study information

• Verified date: November 2023
• Source: Queen Margaret University
• Contact: Georgia Andreopoulou, Msc
• Phone: 07873854432
• Email: GAndreopoulou[@]qmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 29, 2024
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Queen Margeret University	Musselburgh

Sponsors (1)

Lead Sponsor	Collaborator
Queen Margaret University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D gait analysis	The orthotic effect, i.e. the difference in ankle angle with the FES on and off.	Baseline
Secondary	Stroop test/3D gait analysis	Dual task cost of walking speed	Baseline