Effects of Functional Electrical Stimulation Cycling Versus Cycling On
Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking Performance and Quality of Life in Individuals With Multiple Sclerosis: A Pilot Study
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- RT 300: Lower Extremity Cycling
Results by group
Gait Velocity: Timed Walking
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| FES Cycling | 1.33 meters/second | 1.39 (Standard Error) | 7 |
| Cycling Only | 1.4 meters/second | 1.48 (Standard Error) | 7 |
FES Cycling
Cycling Only
Gait Velocity: Timed Walking
4 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| FES Cycling | 1.34 meters/second | 0.18 (Standard Error) | 7 |
| Cycling Only | 1.42 meters/second | 0.18 (Standard Error) | 7 |
FES Cycling
Cycling Only
Gait Velocity: Timed Walking
8 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| FES Cycling | 1.39 meters/second | 0.18 (Standard Error) | 7 |
| Cycling Only | 1.45 meters/second | 0.18 (Standard Error) | 7 |
FES Cycling
Cycling Only
Gait Velocity: Timed Walking
12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| FES Cycling | 1.44 meters/second | 0.18 (Standard Error) | 7 |
| Cycling Only | 1.42 meters/second | 0.18 (Standard Error) | 7 |
FES Cycling
Cycling Only
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| FES Cycling | 7 | 0 (0.0%) | 0 |
| Cycling Only | 7 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Gait Velocity: Timed Walking
Baseline
Disability progressionWalking and mobilityGait Velocity: Timed Walking
4 weeks
Disability progressionWalking and mobilityGait Velocity: Timed Walking
8 weeks
Disability progressionWalking and mobilityGait Velocity: Timed Walking
12 weeks
Disability progressionWalking and mobility
Other measures (6)
Self-reported Fatigue Using Modified Fatigue Impact Scale
Baseline
Thinking and memoryFatigueSelf-reported Fatigue Using Modified Fatigue Impact Scale
8 weeks
Thinking and memoryFatigueSelf-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
Baseline
Walking and mobilitySelf-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
8 weeks
Walking and mobilityOverall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
Baseline
Quality of life (reported by participants)Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
8 weeks
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Nov 2015
Main results due
Jul 2017
Finished
Jul 2017
Results posted
Sept 2019