- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977287
Walking With FES or AFO in People With MS With Foot Drop
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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East Lothian
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Musselburgh, East Lothian, United Kingdom, eh21 6uu
- Queen Margaret University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Other Names:
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in time taken for 10 meter walk test
Time Frame: change from baseline in 10m walk test at 12 weeks
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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.
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change from baseline in 10m walk test at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in distance covered in two minutes
Time Frame: The change from baseline in the the 2 minute walk test at 12 weeks.
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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.
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The change from baseline in the the 2 minute walk test at 12 weeks.
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The change in the MS walking scale (MSWS)
Time Frame: The change from baseline in the MSWS at 12 weeks
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The change from baseline in the MSWS at 12 weeks
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the change in the MS impact scale (MSIS29)
Time Frame: The change from basline in the MSIS29 at 12 weeks
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The change from basline in the MSIS29 at 12 weeks
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The change in the Fatigue Severity Score (FSS)
Time Frame: The change from baseline in the FSS at 12 weeks
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The change from baseline in the FSS at 12 weeks
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The change in the Leeds MS Quality of Life score (LMSQoL)
Time Frame: The change from baseline in the LMSQoL at 12 weeks
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The change from baseline in the LMSQoL at 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marietta L van der Linden, PhD, Queen Margaret University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Multiple Sclerosis
- Sclerosis
- Peroneal Neuropathies
Other Study ID Numbers
- FESvsAFO2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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