Multiple SclerosisNCT03949387
Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis
A study testing FES Cycling Exercise and Passive Leg Cycling in people with Multiple Sclerosis, run by University of Ottawa at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- FES Cycling Exercise and Passive Leg Cycling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2019to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study is an assessor-blinded RCT for examining the efficacy and lasting effects of 24 weeks of supervised FES cycling exercise compared to passive leg cycling on mobility and secondary outcomes in people with MS with mobility impairment. Participants who meet the eligibility criteria will undergo the informed consent process and baseline assessment. Participants will then be randomized to either the FES or passive leg cycling program. Following baseline assessment, participants will complete a 24-week leg cycling program, with a mid-point assessment at 12 weeks. At 24 weeks, participants will undergo a post-intervention assessment. Following a 12-week follow-up period, participants will undergo a final assessment. Each participant will be involved in the study for approximately 10 months.
- Conditions
- Multiple Sclerosis
- Being tested
- FES Cycling Exercise, Passive Leg Cycling
- Keywords
- exercise, multiple sclerosis, mobility
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES Cycling ExerciseOther
FES cycling will use self-adhering surface electrodes (Pals Platinum, Fallbrook, CA) placed over the quadriceps, hamstrings, and gluteal muscle groups to deliver stimulation to the leg muscles.
Passive Leg CyclingOther
Passive leg cycling will not involve electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| FES Cycling Exercise | Experimental | FES cycling will involve systematic, transcutaneous electrical stimulation of the leg muscles to produce leg-cycling movement. The intensity and duration of training will be prescribed based on guidelines for aerobic exercise training for persons with MS and from the American College of Sports Medicine, and will progressively increase across 24 weeks. Participants will be encouraged to actively cycle at a minimum cadence of ~40-50 rpm, at 40-60% VO2peak for between 10-50 minutes. The intensity of stimulation will be adjusted per leg muscle group based on sensory tolerance with the goal of maintaining pedaling action and target heart rate over the entire session. At each session, we will record the distance traveled, energy expended, power output, resistance, heart rate and rating of perceived exertion (RPE). Receives: Other: FES Cycling Exercise |
| Passive Leg Cycling | Placebo comparator | Passive leg cycling will involve movement of the participant's legs by the cycle ergometer motor without electrical stimulation. The duration of training will follow the same schedule as the FES cycling condition and the same data will be recorded at each session. The passive cycling condition will include the same exposure with the training facility, the exercise equipment (i.e. RT300 cycles), and the research staff (i.e. social contact and attention) as with the FES cycling condition. Receives: Other: Passive Leg Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Speed
Walking speed will be assessed using the timed 25-foot walk (T25FW) test. Participants will walk as quickly and safely as possible across a 25-foot distance (2 trials; average reported in m/s).
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Secondary outcomes (11)
Change in Walking Endurance
Walking endurance will be assessed using the 2-minute walk (2MW) test. Participants will walk as fast and as far as possible in an accessible hallway (1 trial, distance traveled recorded in meters).
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Agility
Agility will be assessed using the Timed Up-and-Go (TUG) test. Participants will rise from a chair, walk 3 meters, turn around, walk back to the chair and return to a seated position (2 trials, time recorded in seconds for both trials)
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Patient-rated Mobility Impairment
Patient-rated impact of MS on walking will be captured using the Multiple Sclerosis Walking Scale-12 (MSWS-12). The MSWS-12 is a 12-item questionnaire that assesses the impact of MS on daily functioning with scores ranging from 0 to 100, where higher scores indicate greater walking impairment.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Cognitive Performance: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery involves three cognitive tasks: the oral version of the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test II (CVLT-II), and the revised Brief Visualspatial Memory Test (BVMT-R). The SDMT is a timed thinking task that involves associating numbers with symbols. Participants will be asked to provide as many correct numbers as possible in 90 seconds. The CVLT-II is a test of verbal memory and involves recalling a list of words read aloud by an examiner. The participant will be read a list of 16 words and asked to recall as many words as possible. The BVMT is a test of visual memory which involves recalling and manually drawing a series of 6 abstract designs as accurately as possible. The SDMT is performed once, while there are five trials of the CVLT-II and three trials of the BVMT in the BICAMS battery. Higher scores on all three tests indicate better cognitive function.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Cognitive Performance: Paced Auditory Serial Addition Test (PASAT)
The Paced Auditory Serial Addition Test (PASAT) involves single numerical digits being presented to a participant every 3 seconds. The participant must add each new digit to the one immediately preceding it. There are 61 numbers presented in total and the total number of correct responses is recorded. Higher scores indicate better cognitive function.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Fatigue Impact
Fatigue impact will be assessed using the Modified Fatigue Impact Scale (MFIS). The MFIS is a 21-item questionnaire with three subscales (physical, cognitive, and psychosocial), that assess the impact of fatigue on daily functioning over the past 4 weeks. Total MFIS scores are calculated by summing responses for all 21 items, with higher scores indicating greater impact of fatigue. Subscales are calculated based on a subset of items. Scores range from 0-36, 0-40, and 0-8 for physical, cognitive, and psychosocial subscales, respectively, with higher scores indicating greater fatigue.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Fatigue Severity
Fatigue severity will be assessed by the Fatigue Severity Scale (FSS). The FSS is a nine-item questionnaire that assesses perceived fatigue over the past 7 days. Total FSS scores are calculated as a mean of the nine items. Scores on the FSS range from 1-7, where higher scores indicate more severe fatigue.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Pain
Pain will be assessed using the McGill Pain Questionnaire (MPQ). The MPQ is a 15-item questionnaire which assesses levels of pain experienced by the participants during a 4-week period. The overall score is calculated by summing responses from each item and can range from 0-45, where higher scores indicate greater severity of pain.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Symptoms of Anxiety and Depression
Symptoms of anxiety and depression will be assessed using the 14-item Hospital Anxiety and Depression Scale (HADS). The HADS has two subscales (i.e., anxiety and depression) which each contain 7-items, of which a subset are reserve-scored, and then summed into total scores that range from 0-21. Higher scores on each subscale indicate more frequent symptoms of anxiety and depression.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Health-related Quality of Life
Health-related quality of life will be assessed using the 29-item Multiple Sclerosis Impact Scale (MSIS-29). The MSIS-29 is a measure of physical and psychological health-related QOL. The physical subscale contains 20 items and the psychological subscale contains nine items. Scores from the physical and psychological subscales are computed to range from 0-100, with higher scores indicating a greater physical and psychological impact of MS on daily activities.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Activities of Daily Living
Participation in activities of daily living will be assessed using the abbreviated Late-Life Function and Disability Instrument (LLFDI). The LLDFI contains 15-items within three subscales: basic lower extremity function, advanced lower extremity function, and upper extremity function. Each subscale contains 5-items and scores range from 5-25. A composite score is generated by summing all three subscale scores, and ranges from 15-75, with higher scores indicating fewer functional limitations.
Measured: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start16 Oct 2019
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will use a two-arm, parallel group, single-blinded placebo-controlled RCT design that examines the efficacy and lasting effects of 24-weeks of FES cycling exercise compared to passive leg cycling in persons with MS with mobility impairment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, Multiple Sclerosis Society of Canada
- Responsible party
- Principal investigator, Lara Pilutti, University of Ottawa
- Investigators
- Lara Pilutti, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949387
- Sponsor's protocol ID
- OHSN-REB 20180731-01H
- Status last verified
- Dec 2024
- First submitted
- 6 May 2019
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28881147Pilutti 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.
PubMed 29736463Edwards 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.
PubMed 30243234
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03949387
- Acronym / sponsor ID
- OHSN-REB 20180731-01H
- Conditions
- Multiple Sclerosis
- Keywords
- exercise, multiple sclerosis, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, Multiple Sclerosis Society of Canada
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is an assessor-blinded RCT for examining the efficacy and lasting effects of 24 weeks of supervised FES cycling exercise compared to passive leg cycling on mobility and secondary outcomes in people with MS with mobility impairment. Participants who meet the eligibility criteria will undergo the informed consent process and baseline assessment. Participants will then be randomized to either the FES or passive leg cycling program. Following baseline assessment, participants will complete a 24-week leg cycling program, with a mid-point assessment at 12 weeks. At 24 weeks, participants will undergo a post-intervention assessment. Following a 12-week follow-up period, participants will undergo a final assessment. Each participant will be involved in the study for approximately 10 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will use a two-arm, parallel group, single-blinded placebo-controlled RCT design that examines the efficacy and lasting effects of 24-weeks of FES cycling exercise compared to passive leg cycling in persons with MS with mobility impairment.
| Arm | Type | Receives |
|---|---|---|
| FES Cycling Exercise | Experimental | Other: FES Cycling ExerciseFES cycling will involve systematic, transcutaneous electrical stimulation of the leg muscles to produce leg-cycling movement. The intensity and duration of training will be prescribed based on guidelines for aerobic exercise training for persons with MS and from the American College of Sports Medicine, and will progressively increase across 24 weeks. Participants will be encouraged to actively cycle at a minimum cadence of ~40-50 rpm, at 40-60% VO2peak for between 10-50 minutes. The intensity of stimulation will be adjusted per leg muscle group based on sensory tolerance with the goal of maintaining pedaling action and target heart rate over the entire session. At each session, we will record the distance traveled, energy expended, power output, resistance, heart rate and rating of perceived exertion (RPE). |
| Passive Leg Cycling | Placebo comparator | Other: Passive Leg CyclingPassive leg cycling will involve movement of the participant's legs by the cycle ergometer motor without electrical stimulation. The duration of training will follow the same schedule as the FES cycling condition and the same data will be recorded at each session. The passive cycling condition will include the same exposure with the training facility, the exercise equipment (i.e. RT300 cycles), and the research staff (i.e. social contact and attention) as with the FES cycling condition. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES Cycling ExerciseFES cycling will use self-adhering surface electrodes (Pals Platinum, Fallbrook, CA) placed over the quadriceps, hamstrings, and gluteal muscle groups to deliver stimulation to the leg muscles. | Other | FES Cycling Exercise |
| Passive Leg CyclingPassive leg cycling will not involve electrical stimulation | Other | Passive Leg Cycling |
Primary outcome
Change in Walking Speed
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Walking speed will be assessed using the timed 25-foot walk (T25FW) test. Participants will walk as quickly and safely as possible across a 25-foot distance (2 trials; average reported in m/s).
11 secondary outcomes
Change in Walking Endurance
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Agility
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Patient-rated Mobility Impairment
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Cognitive Performance: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Cognitive Performance: Paced Auditory Serial Addition Test (PASAT)
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Fatigue Impact
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Fatigue Severity
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Pain
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Symptoms of Anxiety and Depression
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Health-related Quality of Life
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Change in Activities of Daily Living
Time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 28881147Edwards 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: PubMed 29736463Pilutti 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: PubMed 30243234Edwards 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Pilutti, PhD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES Cycling Exercise and Passive Leg Cycling in people with Multiple Sclerosis, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking Speed (time frame: Baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949387, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.