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

Queen Margaret University

Status: Completed

Conditions: Multiple Sclerosis; Foot Drop

Treatments: Device: Functional Electrical Stimulation; Device: Ankle Foot Orthosis

Study type: Observational

Funder types: Other

Identifiers

NCT01977287

FESvsAFO2013

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 2 patient groups

Functional Electrical Stimulation

Description:

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.

Treatment:

Device: Functional Electrical Stimulation

Ankle Foot Orthosis

Description:

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.

Treatment:

Device: Ankle Foot Orthosis