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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Queen Margaret University
Sponsor:
Collaborators:
Multiple Sclerosis Society UK
NHS Lothian
Information provided by (Responsible Party):
Marietta van der Linden, Queen Margaret University
ClinicalTrials.gov Identifier:
NCT01977287
First received: October 30, 2013
Last updated: November 5, 2013
Last verified: October 2013
  Purpose

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 Intervention
Multiple Sclerosis
Foot Drop
Device: Functional Electrical Stimulation
Device: Ankle Foot Orthosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Queen Margaret University:

Primary Outcome Measures:
  • Change in time taken for 10 meter walk test [ Time Frame: change from baseline in 10m walk test at 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • change in distance covered in two minutes [ Time Frame: The change from baseline in the the 2 minute walk test at 12 weeks. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • the change in the MS impact scale (MSIS29) [ Time Frame: The change from basline in the MSIS29 at 12 weeks ] [ Designated as safety issue: No ]
  • The change in the Fatigue Severity Score (FSS) [ Time Frame: The change from baseline in the FSS at 12 weeks ] [ Designated as safety issue: No ]
  • The change in the Leeds MS Quality of Life score (LMSQoL) [ Time Frame: The change from baseline in the LMSQoL at 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Names:
  • Odstock Dropped Foot Stimulator (ODFS) III
  • ODFS Pace
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with Multiple Sclerosis who have been prescribed either FES or an AFO to treat foot drop by their physiotherapist.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977287

Contacts
Contact: Marietta L van der Linden, PhD ++ 44 (0)131 4740000 mvanderlinden@qmu.ac.uk

Locations
United Kingdom
Queen Margaret University Recruiting
Musselburgh, East Lothian, United Kingdom, EH21 6UU
Principal Investigator: Marietta L van der Linden, PhD         
Sponsors and Collaborators
Queen Margaret University
Multiple Sclerosis Society UK
NHS Lothian
Investigators
Principal Investigator: Marietta L van der Linden, PhD Queen Margaret University
  More Information

No publications provided

Responsible Party: Marietta van der Linden, Dr, Queen Margaret University
ClinicalTrials.gov Identifier: NCT01977287     History of Changes
Other Study ID Numbers: FESvsAFO2013
Study First Received: October 30, 2013
Last Updated: November 5, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Queen Margaret University:
Multiple Sclerosis
Functional Electrical Stimulation
Ankle Foot Orthosis
Walking performance
gait analysis
fatigue
activity monitoring

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Peroneal Neuropathies
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 14, 2014