The Effects of FES in a Variety of Walking Conditions in... | NCT03410498

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

NCT03410498

Sponsor

Queen Margaret University

Status

Unknown status

Last Update Posted

Nov 18, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

Incremental shuttle walk test

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 29, 2024Estimated

Completion Date

Dec 29, 2024Estimated

First Submitted Date

Jan 17, 2018

First Submission Date that Met QC Criteria

Jan 24, 2018

First Posted Date

Jan 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georgia Andreopoulou, Msc	Contact	07873854432		GAndreopoulou@qmu.ac.uk
Marietta van der Linden, PhD	Contact			mvanderlinden@qmu.ac.uk

Overall Officials

Name	Affiliation	Role
Thomas H Mercer, Prof.	Queen Margaret University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Margeret University	Recruiting	Musselburgh		EH21 6UU	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057190	Stroop Test

Ancestor Terms

ID	Term
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided