Walking With FES or AFO in People With MS With Foot Drop

April 1, 2016 updated by: Marietta van der Linden, Queen Margaret University

A Pilot Study to Assess the Effects of Using FES or AFO as an Assistive Mobility for Period of 12 Weeks for People With Multiple Sclerosis With Foot Drop

This investigation consists of two parallel groups of participants who will follow the same protocol. The aim of the study is to investigate the effects of using Functional Electrical Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12 week period in people with MS who experience foot drop. Patients who are clinically prescribed FES will be invited to participate in the FES arm of the study. Patients who are clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6 weeks and 12 weeks of device use. Participants' walking will assessed using computerised three dimensional motion analysis, which will provide a detailed description of the movements (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk and a two minute walk. Both gait analysis and the walking performance tests will be carried out with and without an assistive device; apart from their first session where participants will only be assessed without their assistive device.

Participants will be asked to wear an activity monitor for 7 days after each assessment. In addition participants will be asked to complete four short standardised questionnaires (MS walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of life score) at each assessment.

Study Overview

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • East Lothian
      • Musselburgh, East Lothian, United Kingdom, eh21 6uu
        • Queen Margaret University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with Multiple Sclerosis who have been prescribed either FES or an AFO to treat foot drop by their physiotherapist.

Description

Inclusion Criteria:

  • People diagnosed with Multiple Sclerosis
  • Prescribed either AFO or FES to treat drop foot by their physiotherapist
  • aged 18-75

Exclusion Criteria:

  • Unable to walk 10 meters
  • Bilateral device use
  • Breastfeeding or pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Functional Electrical Stimulation
The Functional Electrical Stimulation (FES) group will be asked to use their clinically prescribed FES unit (either ODFS III or Pace) to the dorsiflexors to treat foot drop for a period of 12 weeks.
Other Names:
  • Odstock Dropped Foot Stimulator (ODFS) III
  • ODFS Pace
Ankle Foot Orthosis
The people in the Ankle Foot Orthosis group (AFO) will be asked to use their clinically prescribed AFO to treat drop foot for a period of 12 weeks.
Other Names:
  • splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in time taken for 10 meter walk test
Time Frame: change from baseline in 10m walk test at 12 weeks
In the 10 meter walk test, the time taken by the participant to walk 10 meters is recorded. The test is repeated and the average is taken for analysis.
change from baseline in 10m walk test at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ankle dorsiflexion angle at initial contact
Time Frame: The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks
The ankle dorsiflexion angle is derived from gait analysis. The angle of the ankle at the time the foot contacts the floor during a step is derived. This is repeated for at least 5 different walks, and the average of those 5 walks is calculated for further analysis.
The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in distance covered in two minutes
Time Frame: The change from baseline in the the 2 minute walk test at 12 weeks.
During the 2 minute walk test the participant walks around an oval shaped track for 2 minutes. The distance covered in two minutes is taken for analysis.
The change from baseline in the the 2 minute walk test at 12 weeks.
The change in the MS walking scale (MSWS)
Time Frame: The change from baseline in the MSWS at 12 weeks
The change from baseline in the MSWS at 12 weeks
the change in the MS impact scale (MSIS29)
Time Frame: The change from basline in the MSIS29 at 12 weeks
The change from basline in the MSIS29 at 12 weeks
The change in the Fatigue Severity Score (FSS)
Time Frame: The change from baseline in the FSS at 12 weeks
The change from baseline in the FSS at 12 weeks
The change in the Leeds MS Quality of Life score (LMSQoL)
Time Frame: The change from baseline in the LMSQoL at 12 weeks
The change from baseline in the LMSQoL at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marietta L van der Linden, PhD, Queen Margaret University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

April 1, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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