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

University of Ottawa

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Passive Leg Cycling; Other: FES Cycling Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03949387

OHSN-REB 20180731-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

10 participants in 2 patient groups, including a placebo group

FES Cycling Exercise

Experimental group

Description:

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).

Treatment:

Other: FES Cycling Exercise

Passive Leg Cycling

Placebo Comparator group

Description:

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.

Treatment:

Other: Passive Leg Cycling