An interventional study of Active cycling and Passive cycling in Secondary Progressive Multiple Sclerosis, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling will improve walking in subjects with SPMS.
Individuals with secondary progressive multiple sclerosis (SPMS) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. Treatment attempts for progressive MS have been disappointing. No therapeutic intervention has been shown to modulate disability in patients with SPMS. FES cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory central nervous system (CNS) environment in progressive MS. The investigators are proposing a novel, and easy to implement intervention strategy of FES cycling to help improve gait function in individuals with SPMS. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. FES is easily transferable to clinical practice and could potentially ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost. In addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.
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Exclusion Criteria:
Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal.
Behavioral: Active cycling
Individuals will receive active functional electrical stimulation (FES) while on the stationary bike and instructed to relax their legs, allowing the FES to move their legs on the stationary bike.
Behavioral: Passive cycling
The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to actively pedal while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
Also known as: cycling, endurance training
The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to sit passively on the stationary bile while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
Also known as: letting the functional electrical stimulation move the legs
Change in timed 25 foot walk from baseline to end of training
Here we will assess whether a subjects walking speed is improved following active cycling with functional electrical stimulation. Our prediction is that individuals will improve in their walking function following seated active cycling with functional electrical stimulation.
Time frame: Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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