Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS (MSCycling)

Stony Brook University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: RT 300: Lower Extremity Cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT02606604

534378-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

FES Cycling

Experimental group

Description:

The intervention consists of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed).

Treatment:

Device: RT 300: Lower Extremity Cycling

Cycling Only

Active Comparator group

Description:

The intervention consists of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks. Electrical stimulation will not be applied to any muscles. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed.

Treatment:

Device: RT 300: Lower Extremity Cycling