Clinical trial NCT01977287: Walking With FES or AFO in People With MS With Foot Drop
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Foot Drop
Keywords: Multiple Sclerosis
Functional Electrical Stimulation
Ankle Foot Orthosis
Walking performance
gait analysis
fatigue
activity monitoring
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society UK
name: NHS Lothian
First posted: 2013-11-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in time taken for 10 meter walk test
timeFrame: change from baseline in 10m walk test at 12 weeks
Secondary outcomes:
measure: Change in ankle dorsiflexion angle at initial contact
timeFrame: The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks
Other outcomes:
measure: change in distance covered in two minutes
timeFrame: The change from baseline in the the 2 minute walk test at 12 weeks.
measure: The change in the MS walking scale (MSWS)
timeFrame: The change from baseline in the MSWS at 12 weeks
measure: the change in the MS impact scale (MSIS29)
timeFrame: The change from basline in the MSIS29 at 12 weeks
measure: The change in the Fatigue Severity Score (FSS)
timeFrame: The change from baseline in the FSS at 12 weeks
measure: The change in the Leeds MS Quality of Life score (LMSQoL)
timeFrame: The change from baseline in the LMSQoL at 12 weeks
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen Margaret University
state: East Lothian
Study officials:
affiliation: Queen Margaret University
name: Marietta L van der Linden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.