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Functional Electrical Stimulation for People With Multiple Sclerosis Who Experience Foot Drop

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
prolonged walk
Sponsored by
Queen Margaret University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • People with MS (aged 18-80) who are assessed for their suitability for FES to treat foot-drop between September 2013 and March 2014 at Slateford Medical Centre are eligible for participation in this study

Exclusion Criteria:

  • Patients with fixed ankle deformities, who are allergic to tape and who are unable to walk for at least for two minutes (with or without walking aids) will be excluded.
  • Patients who experienced a relapse or any trauma affecting their walking between the first fitting appointment and the follow-up appointment will also be excluded from the study.

Sites / Locations

  • Slateford medical centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

prolonged walk

Arm Description

Outcomes

Primary Outcome Measures

Peak dorsiflexion angle during the swing phase without FES
The electrogoniometer record the (sagittal) ankle angle during the 2-6 minute walk around the physiotherapy department. In the data processing stage, the peak dorsiflexion angle during the swing phase will be determined for each gait cycle over a period of 20 seconds at the start and at the end of the walk.

Secondary Outcome Measures

Rate of perceived exertion (RPE)
The participant will be asked to rate his/her perceived exertion on the Borg Scale (6-20) at minute intervals during the walk.
Peak dorsiflexion angle during swing phase (with FES)
The electrogoniometer record the (sagittal) ankle angle during the 2-6 minute walk around the physiotherapy department. In the data processing stage, the peak dorsiflexion angle during the swing phase will be determined for each gait cycle over a period of 20 seconds at the start and at the end of the walk.
Rates of perceived Exertion (RPE) with FES
The participant will be asked to rate his/her perceived exertion on the Borg Scale (6-20) at minute intervals during the walk

Full Information

First Posted
June 25, 2013
Last Updated
September 27, 2016
Sponsor
Queen Margaret University
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT01914016
Brief Title
Functional Electrical Stimulation for People With Multiple Sclerosis Who Experience Foot Drop
Official Title
Functional Electrical Stimulation for People With Multiple Sclerosis Who Experience Foot Drop:Feasibility of Instrumented Gait Analysis in Clinical Practice.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
People with Multiple Sclerosis (pwMS) often experience 'foot-drop' which means that the foot is not adequately lifted during the so-called swing phase (foot is off the ground) during walking which can lead to trips and falls. Functional Electrical Stimulation (FES) to the shin muscles will aid lifting of the foot and therefore reduces the risk of trips and falls. There have been several studies showing the benefits of FES to the walking of pwMS. The proposed study aims to optimise the FES prescription and fitting care pathway for pwMS in Edinburgh and the Lothians This will be achieved firstly through a survey to all clients with MS in the last 5 years who have been regarded as suitable for FES. Secondly, a pilot study will assess the suitability of the use of simple clinical measurement (electrogoniometry) which will allow the measurement of the degree of foot-drop. The degree is foot drop is usually assessed by the physiotherapist using visual observation. Using a small device which can be quickly fitted to the patient's lower and foot for the duration of a 2-6 minute walk, the physiotherapist will be able to quantify the degree of foot drop over time. Such a measurement is especially important for people with MS who are often affected by increased mental and physical fatigue. Our first hypothesis is that the degree of foot-drop at the end of the walk is increased compared to the start of the walk. Secondly, we hypothesise that the degree of foot drop is less when the participant walks with the assistance of Functional Electrical Stimulation at their next clinical appointment.
Detailed Description
Participants People with MS (aged 18 or over) who are assessed for their suitability for FES to treat foot-drop at Slateford Medical Centre are eligible for participation in this study. For this feasibility study we aim to recruit at least 10 participants. Recruitment Eligible patients will be given an information sheet by their physiotherapist who will introduce the study at their initial appointment. A second appointment is made to fit the FES unit and if the patient is willing to consider taking part in the study, informed consent is taken. Data collection To record the degree of foot-drop, one arm of the electrogoniometer will be attached to the side of the participant's lower leg and the other arm to the shoe using skin-friendly double sided adhesive tape. The participant will then be asked to walk in their normal walking speed around the corridors of the clinic for six minutes or shorter if the participant is not able to walk for this duration. A data logger carried on the belt on the participant's waist will continuously record the ankle angle data at 50Hz. Walking speed will be derived by measuring the distance walked in the time recorded. Rate of perceived exertion on the Borg Scale will be recorded every minute and immediately after the walk. Participants will also be asked to fill in a questionnaire on their perceived walking performance (Multiple Sclerosis Walking Scale 12). At a follow-up appointment (1-2 weeks later) this data collection will be repeated with the participant using the FES unit. Data analysis. To assess the impact of fatigue on the ankle angle during prolonged walking, ankle angle data in the first and last 60 seconds of the walk will be recorded. Two way ANOVA will be employed to analyse both the effects of time (within session) and that of FES use ('Off' and 'On', between sessions) on the degree of foot-drop if data are normally distributed. Equivalent non-parametric statistics will be used for non normally distributed data. Statistical significance will be accepted at p<0.05. Inclusion criteria People with MS (aged 18-80) who are assessed for their suitability for FES to treat foot-drop between September 2013 and March 2014 at Slateford Medical Centre are eligible for participation in this study. Exclusion criteria Patients with fixed ankle deformities, who are allergic to tape and who are unable to walk for at least for two minutes (with or without walking aids) will be excluded. Patients who experienced a relapse or any trauma affecting their walking between the first fitting appointment and the follow-up appointment will also be excluded from the study.

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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prolonged walk
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
prolonged walk
Intervention Description
Participants will be asked to walk for a duration of between 2 -6 minutes until they rate their perceived exertion as 'Hard' (RPE 16 on Borg Scale)
Primary Outcome Measure Information:
Title
Peak dorsiflexion angle during the swing phase without FES
Description
The electrogoniometer record the (sagittal) ankle angle during the 2-6 minute walk around the physiotherapy department. In the data processing stage, the peak dorsiflexion angle during the swing phase will be determined for each gait cycle over a period of 20 seconds at the start and at the end of the walk.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Rate of perceived exertion (RPE)
Description
The participant will be asked to rate his/her perceived exertion on the Borg Scale (6-20) at minute intervals during the walk.
Time Frame
Baseline
Title
Peak dorsiflexion angle during swing phase (with FES)
Description
The electrogoniometer record the (sagittal) ankle angle during the 2-6 minute walk around the physiotherapy department. In the data processing stage, the peak dorsiflexion angle during the swing phase will be determined for each gait cycle over a period of 20 seconds at the start and at the end of the walk.
Time Frame
two weeks from baseline
Title
Rates of perceived Exertion (RPE) with FES
Description
The participant will be asked to rate his/her perceived exertion on the Borg Scale (6-20) at minute intervals during the walk
Time Frame
2 weeks from baseline
Other Pre-specified Outcome Measures:
Title
MS walking scale
Description
The participant will be asked to fill in the MS walking scale, for both without (first visit) and with walking with the assistance of FES (second visit) in mind.
Time Frame
baseline and 2 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People with MS (aged 18-80) who are assessed for their suitability for FES to treat foot-drop between September 2013 and March 2014 at Slateford Medical Centre are eligible for participation in this study Exclusion Criteria: Patients with fixed ankle deformities, who are allergic to tape and who are unable to walk for at least for two minutes (with or without walking aids) will be excluded. Patients who experienced a relapse or any trauma affecting their walking between the first fitting appointment and the follow-up appointment will also be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marietta L van der Linden, PhD
Organizational Affiliation
Queen Margaret University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Slateford medical centre
City
Edinburgh
ZIP/Postal Code
EH4 1NQ
Country
United Kingdom

12. IPD Sharing Statement

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Functional Electrical Stimulation for People With Multiple Sclerosis Who Experience Foot Drop

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