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

NCT ID: NCT02606604

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-07-31

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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FES Cycling

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).

Group Type: EXPERIMENTAL

RT 300: Lower Extremity Cycling

Intervention Type: DEVICE

Individuals will be randomly assigned to either the FES cycling or cycling only group and will perform lower extremity cycling. Individuals will participate in an interval training cycling program 3 times per week for 8 weeks.

Cycling Only

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.

Group Type: ACTIVE_COMPARATOR

RT 300: Lower Extremity Cycling

Intervention Type: DEVICE

Individuals will be randomly assigned to either the FES cycling or cycling only group and will perform lower extremity cycling. Individuals will participate in an interval training cycling program 3 times per week for 8 weeks.

Interventions

RT 300: Lower Extremity Cycling

Individuals will be randomly assigned to either the FES cycling or cycling only group and will perform lower extremity cycling. Individuals will participate in an interval training cycling program 3 times per week for 8 weeks.

Intervention Type: DEVICE

Other Intervention Names

RT 300; Lower Extremity Ergometer

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Lori Hochman

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori I Hochman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook Univeristy

Stony Brook, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

534378-1

Identifier Type: -

Identifier Source: org_study_id