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

NCT01977287 | Completed

• 1 other identifier: FESvsAFO2013
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Foot Drop

Keywords

Multiple Sclerosis; Functional Electrical Stimulation; Ankle Foot Orthosis; Walking performance; gait analysis; fatigue; activity monitoring

Outcome Measures

Primary Outcomes (1)

• Change in time taken for 10 meter walk test

  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 Outcomes (1)

• Change in ankle dorsiflexion angle at initial contact

  The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks

Other Outcomes (5)

• change in distance covered in two minutes

  The change from baseline in the the 2 minute walk test at 12 weeks.

• The change in the MS walking scale (MSWS)

  The change from baseline in the MSWS at 12 weeks

• the change in the MS impact scale (MSIS29)

  The change from basline in the MSIS29 at 12 weeks

Study Arms (2)

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.

Device: Functional Electrical Stimulation

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.

Device: Ankle Foot Orthosis

Interventions

Functional Electrical Stimulation DEVICE

Also known as: Odstock Dropped Foot Stimulator (ODFS) III, ODFS Pace

Functional Electrical Stimulation

Ankle Foot Orthosis DEVICE

Also known as: splint

Ankle Foot Orthosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen Margaret University: lead
• Multiple Sclerosis Society UK: collaborator
• NHS Lothian: collaborator

Study Sites (1)

Queen Margaret University

Musselburgh, East Lothian, EH21 6UU, United Kingdom

Location

Related Publications (1)

• van der Linden ML, Hooper JE, Cowan P, Weller BB, Mercer TH. Habitual functional electrical stimulation therapy improves gait kinematics and walking performance, but not patient-reported functional outcomes, of people with multiple sclerosis who present with foot-drop. PLoS One. 2014 Aug 18;9(8):e103368. doi: 10.1371/journal.pone.0103368. eCollection 2014.

  PMID: 25133535 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Peroneal Neuropathies; Fatigue

Interventions

Splints

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Marietta L van der Linden, PhD

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: June 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 4, 2016

Record last verified: 2016-04

Locations

GB (1)