Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01647321|
Recruitment Status : Recruiting
First Posted : July 23, 2012
Last Update Posted : September 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Secondary Progressive Multiple Sclerosis||Behavioral: Active cycling Behavioral: Passive cycling||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis|
|Actual Study Start Date :||July 2012|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Active cycling
Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal.
Behavioral: Active 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.
Sham Comparator: Passive 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 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.
Other Name: letting the functional electrical stimulation move the legs
- Change in timed 25 foot walk from baseline to end of training [ 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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647321
|Contact: Sandi Cassardfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins / Kennedy Krieger Institute||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator: S Newsome, MD|