NCT03949387

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Ottawa · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	Passive Leg Cycling	Passive leg cycling will not involve electrical stimulation

Timeline

• Start date: 2019-10-16
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2019-05-14
• Last updated: 2024-12-24

Locations

1 site across 1 country: Canada