Walking With FES or AFO in People With MS With Foot Drop
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|ClinicalTrials.gov Identifier: NCT01977287|
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : April 4, 2016
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.
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis Foot Drop||Device: Functional Electrical Stimulation Device: Ankle Foot Orthosis|
|Study Type :||Observational|
|Actual Enrollment :||18 participants|
|Observational Model:||Case Control|
|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 Start Date :||June 2011|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Functional Electrical Stimulation
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.
Device: Functional Electrical Stimulation
Ankle Foot Orthosis
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.
Device: Ankle Foot Orthosis
Other Name: splint
- Change in time taken for 10 meter walk test [ Time Frame: 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.
- Change in ankle dorsiflexion angle at initial contact [ Time Frame: 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.
- change in distance covered in two minutes [ Time Frame: 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 MS walking scale (MSWS) [ Time Frame: The change from baseline in the MSWS at 12 weeks ]
- the change in the MS impact scale (MSIS29) [ Time Frame: The change from basline in the MSIS29 at 12 weeks ]
- The change in the Fatigue Severity Score (FSS) [ Time Frame: The change from baseline in the FSS at 12 weeks ]
- The change in the Leeds MS Quality of Life score (LMSQoL) [ Time Frame: The change from baseline in the LMSQoL at 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977287
|Queen Margaret University|
|Musselburgh, East Lothian, United Kingdom, EH21 6UU|
|Principal Investigator:||Marietta L van der Linden, PhD||Queen Margaret University|