Clinical trial NCT02606604: Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS
Official title: Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking Performance and Quality of Life in Individuals With Multiple Sclerosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Functional Electrical Stimulation
Cycling
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Functional Electrical Stimulation (FES) is a rehabilitation tool that stimulates nerves via electrical current, causing muscles to contract. When FES is appled to leg muscles during stationary cycling the legs move in a fixed rhythmical pattern. Previous studies have demonstrated that FES during cycling is a safe and effective exercise for individuals recovering from spinal cord injury or stroke, but few have applied this tool to a progressive disorder, such as multiple sclerosis (MS). The aim of this study is to assess the immediate and short-term effect of an 8-week training program comparing FES lower extremity cycling to cycling without FES. Twenty volunteers with MS will participate. They will be randomly assigned to a training group. This study examine the effects of training on quality of life, endurance, walking speed, and step quality. Participants will sign an informed consent and complete a questionnaire that includes medical history and demographic data. Before training, immediately after training finishes and one month after training, self-report questionnaires, timed walking tests will be completed. During the walking tests, step quality and speed will be measured with a sensor that is worn on a belt

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

Primary outcomes:
measure: Gait Velocity: Timed Walking
timeFrame: Baseline
measure: Gait Velocity: Timed Walking
timeFrame: 4 weeks
measure: Gait Velocity: Timed Walking
timeFrame: 8 weeks
measure: Gait Velocity: Timed Walking
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-reported Fatigue Using Modified Fatigue Impact Scale
timeFrame: Baseline
measure: Self-reported Fatigue Using Modified Fatigue Impact Scale
timeFrame: 8 weeks
measure: Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
timeFrame: Baseline
measure: Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
timeFrame: 8 weeks
measure: Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
timeFrame: Baseline
measure: Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Univeristy
state: New York
Study officials:
affiliation: Stony Brook University
name: Lori I Hochman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: