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

NCT01914016 | Completed

• 1 other identifier: QMU ELHF109-121
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (3)

• Rate of perceived exertion (RPE)

  Baseline

• Peak dorsiflexion angle during swing phase (with FES)

  two weeks from baseline

• Rates of perceived Exertion (RPE) with FES

  2 weeks from baseline

Other Outcomes (1)

• MS walking scale

  baseline and 2 weeks from baseline

Study Arms (1)

prolonged walk

OTHER

Other: prolonged walk

Interventions

prolonged walk OTHER

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)

prolonged walk

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Margaret University: lead
• NHS Lothian: collaborator

Study Sites (1)

Slateford medical centre

Edinburgh, EH4 1NQ, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Marietta L van der Linden, PhD

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: August 1, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

GB (1)