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Clinical Trials/NCT02606604
NCT02606604
Completed
N/A

Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking Performance and Quality of Life in Individuals With Multiple Sclerosis: A Pilot Study

Stony Brook University1 site in 1 country15 target enrollmentNovember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Stony Brook University
Enrollment
15
Locations
1
Primary Endpoint
Gait Velocity: Timed Walking
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
July 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lori Hochman

Clinical Assistant Professor

Stony Brook University

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

Outcomes

Primary Outcomes

Gait Velocity: Timed Walking

Time Frame: 12 weeks

Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

Secondary Outcomes

  • Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54(8 weeks)
  • Self-reported Fatigue Using Modified Fatigue Impact Scale(8 weeks)
  • Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale(8 weeks)

Study Sites (1)

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