Multiple Sclerosis, Foot Drop
Conditions
Keywords
Multiple Sclerosis, Functional Electrical Stimulation, Ankle Foot Orthosis, Walking performance, gait analysis, fatigue, activity monitoring
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.
Interventions
DEVICEFunctional Electrical Stimulation
DEVICEAnkle Foot Orthosis
Sponsors
Multiple Sclerosis Society UK
NHS Lothian
Queen Margaret University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| the change in the MS impact scale (MSIS29) | The change from basline in the MSIS29 at 12 weeks | — |
| change in distance covered in two minutes | 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 in the Leeds MS Quality of Life score (LMSQoL) | The change from baseline in the LMSQoL at 12 weeks | — |
| The change in the Fatigue Severity Score (FSS) | The change from baseline in the FSS at 12 weeks | — |
| The change in the MS walking scale (MSWS) | The change from baseline in the MSWS at 12 weeks | — |
Countries
United Kingdom
Outcome results
None listed