Functional Electrical Stimulation Cycling for Managing Mobility Disabi
Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- FES Cycling Exercise
Placebo
- Passive Leg Cycling
What it measured
Main measures
Change in Walking Speed
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Disability progressionWalking and mobility
Other measures (11)
Change in Walking Endurance
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Walking and mobilityChange in Agility
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Walking and mobilityChange in Patient-rated Mobility Impairment
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Walking and mobilityChange in Cognitive Performance: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Thinking and memoryChange in Cognitive Performance: Paced Auditory Serial Addition Test (PASAT)
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Thinking and memoryChange in Fatigue Impact
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Thinking and memoryFatigueChange in Fatigue Severity
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
FatigueChange in Pain
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
PainChange in Symptoms of Anxiety and Depression
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Mood and sleepChange in Health-related Quality of Life
Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 64 · EDSS 5.0 to 7.0
Show the full criteria
Inclusion criteria
* diagnosis of multiple sclerosis * relapse free in the past 30 days * stable course of disease-modifying therapies over the past 6 months * ability to communicate in English * willing to come to the University of Ottawa to complete testing and training sessions * EDSS score 5.0 - 7.0 * asymptomatic based on a physical activity pre-participation screening tool
Exclusion criteria
* presence of any contraindication to FES including epilepsy, a pacemaker, implanted defibrillator, unstable fracture, or pregnancy * diagnosis of other neurological condition(s) * participation in FES cycling exercise or other mobility-based exercise rehabilitation program within the past 6 months * current use of dalfampridine within the past month
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Mobility impairment is one of the most common, poorly managed, and life altering consequences of MS. Current therapies for managing MS do not prevent the long-term accumulation of mobility impairment, highlighting the need for alternative strategies that prevent or slow progressive mobility disability. The proposed trial will test the efficacy and lasting effects of functional electrical stimulation (FES) cycling as an exercise-based rehabilitation strategy for managing mobility impairment and associated consequences in MS.
Papers
Background
Edwards T, Motl RW, Pilutti LA. Cardiorespiratory demand of acute voluntary cycling with functional electrical stimulation in individuals with multiple sclerosis with severe mobility impairment. Appl Physiol Nutr Metab. 2018 Jan;43(1):71-76. doi: 10.1139/apnm-2017-0397. Epub 2017 Sep 7.Background
Pilutti LA, Motl RW, Edwards TA, Wilund KR. Rationale and design of a randomized controlled clinical trial of functional electrical stimulation cycling in persons with severe multiple sclerosis. Contemp Clin Trials Commun. 2016 May 15;3:147-152. doi: 10.1016/j.conctc.2016.05.005. eCollection 2016 Aug 15.Background
Edwards T, Motl RW, Sebastiao E, Pilutti LA. Pilot randomized controlled trial of functional electrical stimulation cycling exercise in people with multiple sclerosis with mobility disability. Mult Scler Relat Disord. 2018 Nov;26:103-111. doi: 10.1016/j.msard.2018.08.020. Epub 2018 Sep 8.
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History
- Result signal changed from Finished, results not yet expected to Finished, no results found
Started
Oct 2019
Main results due
Oct 2024
Finished
Oct 2024