Functional Electrical Stimulation Cycling for Managing Mobility Disability in People With Multiple Sclerosis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 56
Summary
- Conditions
- Multiple Sclerosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Outcomes Assessor)Masking Description: Outcome assessments will be collected objectively by researchers who are blinded to treatment allocation. Researchers who are involved with delivery of the intervention will be aware of treatment allocation, but will not be involved with data collection, entry or analysis.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 64 years
- Gender
- Both males and females
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 underg...
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.
Tracking Information
- NCT #
- NCT03949387
- Collaborators
- The Ottawa Hospital
- Multiple Sclerosis Society of Canada
- Investigators
- Principal Investigator: Lara Pilutti, PhD University of Ottawa
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