Functional Electrical Stimulation to Treat Foot Drop in People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT02123537

What it found

No results found

We found no results in the registry or in papers.

This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Bioness L300 Foot Drop System

What it measured

Main measures

  • Speed during the 10-metre straight line walking test

    12 weeks

    Walking and mobility

Other measures (10)

  • Distance travelled during the 4-minute figure-8 walking test

    12 weeks

    Walking and mobility
  • Speed during the 10-metre straight line walking test

    4 weeks

    Walking and mobility
  • Speed during the 10-metre straight line walking test

    8 weeks

    Walking and mobility
  • Distance travelled during the 4-minute figure-8 walking test

    4 weeks

    Walking and mobility
  • Distance travelled during the 4-minute figure-8 walking test

    8 weeks

    Walking and mobility
  • Physiological cost index during walking tests

    4 weeks

    Walking and mobility
  • Physiological cost index during walking tests

    8 weeks

    Walking and mobility
  • Physiological cost index during walking tests

    12 weeks

    Walking and mobility
  • Participant satisfaction questionnaire score

    12 weeks

    Quality of life (reported by participants)
  • Treadmill Gait Assessment

    12 weeks

    Walking and mobility

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Have multiple sclerosis for at least one year * Being 18 years of age or older * Have upper motor neuron-type foot drop (based on the study clinician's medical opinion) * Able to ambulate at least 10 metres independently or with one person assistance, with or without walking aid * Having the cognitive capacity to understand and follow the study protocol

Exclusion criteria

* Severe cardio-respiratory difficulties (including using a pace-maker) or other health issues that may prohibit walking training * Significant lower motor neuron neuropathy (based on the study clinician's medical opinion) * History of frequent falls (more than once a week) * Having used functional electrical stimulation to treat gait within the past six months

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

People with multiple sclerosis (MS) often suffer from foot drop, which impairs their walking ability. Foot drop is the inability to lift the foot during the swing phase of walking. The purpose of this study is to find out if electrical stimulation of the leg, using the Bioness L300 Foot Drop System, can be used to treat foot drop in people with MS. It is expected that using this system will reduce foot drop, and therefore improve walking ability, particularly in the areas of speed, strength, balance and falls.

Papers

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History

    1. Started

      Jun 2014

    2. Main results due

      Jul 2016

    3. Finished

      Jul 2016

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