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| Name | Class |
|---|---|
| Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active cycling | Active Comparator | Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal. |
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| Passive cycling | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active cycling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Newsome, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins / Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000076663 | Endurance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Passive cycling | Behavioral | 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. |
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|
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |