Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis

NCT ID: NCT03949387

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2024-10-28

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

exercise; multiple sclerosis; mobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FES Cycling Exercise

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).

Group Type: EXPERIMENTAL

FES Cycling Exercise

Intervention Type: OTHER

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 Cycling

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.

Group Type: PLACEBO_COMPARATOR

Passive Leg Cycling

Intervention Type: OTHER

Passive leg cycling will not involve electrical stimulation

Interventions

FES Cycling Exercise

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.

Intervention Type: OTHER

Passive Leg Cycling

Passive leg cycling will not involve electrical stimulation

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ottawa

OTHER

Sponsor Role: lead

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

Multiple Sclerosis Society of Canada

OTHER

Sponsor Role: collaborator

Responsible Party

Lara Pilutti

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara Pilutti, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Locations

University of Ottawa

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 28881147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29736463 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30243234 (View on PubMed)

Other Identifiers

OHSN-REB 20180731-01H

Identifier Type: -

Identifier Source: org_study_id