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

Completed

• Conditions: Foot Drop; Multiple Sclerosis

• Registration Number: NCT01977287
• Lead Sponsor: Queen Margaret University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in time taken for 10 meter walk test	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.

Secondary Outcome Measures

Name	Time	Method
Change in ankle dorsiflexion angle at initial contact	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.

Trial Locations

Locations (1)

Queen Margaret University; 🇬🇧 Musselburgh, East Lothian, United Kingdom