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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977287
• Other study ID #: FESvsAFO2013
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: April 1, 2016
• Start date: June 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Foot Drop
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Functional Electrical Stimulation

• Ankle Foot Orthosis

Locations

Country	Name	City	State
United Kingdom	Queen Margaret University	Musselburgh	East Lothian

Sponsors (3)

Lead Sponsor	Collaborator
Queen Margaret University	Multiple Sclerosis Society UK, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in distance covered in two minutes	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 from baseline in the the 2 minute walk test at 12 weeks.	No
Other	The change in the MS walking scale (MSWS)		The change from baseline in the MSWS at 12 weeks	No
Other	the change in the MS impact scale (MSIS29)		The change from basline in the MSIS29 at 12 weeks	No
Other	The change in the Fatigue Severity Score (FSS)		The change from baseline in the FSS at 12 weeks	No
Other	The change in the Leeds MS Quality of Life score (LMSQoL)		The change from baseline in the LMSQoL at 12 weeks	No
Primary	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	No
Secondary	Change in ankle dorsiflexion angle at initial contact	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.	The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks	No