N/A
Completed N=15
Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS
Source: ClinicalTrials.gov NCT02606604 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Gait Velocity: Timed Walking — 1.33; 1.4 meters/second
Summary
This study will seek to determine the benefits that FES-LE cycling has over cycling alone on walking performance and quality of life in people with multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Velocity: Timed Walking |
1.44; 1.42 | — |
| SECONDARY Self-reported Fatigue Using Modified Fatigue Impact Scale |
32; 39.57 | — |
| SECONDARY Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale |
59.91; 69.52 | — |
| SECONDARY Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54 |
70.95; 60.95 | — |
Eligibility Criteria
Inclusion Criteria
- Medical Diagnosis of MS
- Patient-determined Disease Steps score between 3.0 and 6.0 inclusive
- Ability to attend training sessions 3 times per week for an 8-10 week period
- Passing a submaximal exercise test
- Adequate hip range of motion (at least 110 degrees)
- Adequate knee range of motion (10-90 degrees)
Exclusion Criteria
- Cognitive deficits that would interfere in ability to sign consent and understand the procedures for the study.
- History or presence of other neurological pathologies that interfere with movement
- Received physical therapy within the last 4 weeks prior to the study
- History of an acute exacerbation of their MS symptoms within 4 weeks prior to the study
- Immunosuppressive or steroid therapy within the past 4 weeks
- Significant spasticity in the legs that interferes with the cycling motion
- History of congestive heart failure
- Coronary Artery Disease
- Uncontrolled Hypertension
- History of epilepsy or seizures
- Cardiac demand pacemaker or implanted defibrillator
- Unhealed fractures in the legs
- Pressure sores or open wounds on the legs
- Pregnant or trying to conceive
Data sourced from ClinicalTrials.gov (NCT02606604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.