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Completed

NCT Number: NCT02606604

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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook Univeristy

Stony Brook, New York, 11794, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RT 300: Lower Extremity Cycling

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.

Other names: RT 300, Lower Extremity Ergometer

Primary outcomes

  1. Gait Velocity: Timed Walking

    Time frame: Baseline

    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.

  2. Gait Velocity: Timed Walking

    Time frame: 4 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.

  3. Gait Velocity: Timed Walking

    Time frame: 8 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.

  4. 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

  1. Self-reported Fatigue Using Modified Fatigue Impact Scale

    Time frame: Baseline

    The Modified Fatigue Impact Scale is a 21 item self-report questionnaire that takes 5-10 minutes to complete. It uses a 5-point likert scale to rate the patient's perception of how Multiple Sclerosis related fatigue affects an individual's life on an everyday basis. It contains three subscales that include: cognitive, physical, and psychosocial dimensions. Scores on the subscales can be analyzed individually or as a summed score to give an overall fatigue score. Higher scores indicate a greater impact of fatigue. The minimum score is a 0 and the maximum score is 81.

  2. Self-reported Fatigue Using Modified Fatigue Impact Scale

    Time frame: 8 weeks

    The Modified Fatigue Impact Scale is a 21 item self-report questionnaire that takes 5-10 minutes to complete. It uses a 5-point likert scale to rate the patient's perception of how Multiple Sclerosis related fatigue affects an individual's life on an everyday basis. It contains three subscales that include: cognitive, physical, and psychosocial dimensions. Scores on the subscales can be analyzed individually or as a summed score to give an overall fatigue score. Higher scores indicate a greater impact of fatigue. The minimum score is a 0 and the maximum score is 81.

  3. Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale

    Time frame: Baseline

    The Multiple Sclerosis Walking Scale is a 12-item self-report questionnaire that takes approximately 10 minutes to complete and reflects a persons' perception of the impact that multiple sclerosis has on walking ability during the past 2 weeks. Each of the items scored ranges from 1 to 5, in which higher scores indicate a greater impact of multiple sclerosis on their walking. Scores on the 12 items are summed. To transform to a 0-100 scale, the minimum score of 12 is subtracted from the sum; the result is divided by 48 and then multiplied by 100. The lowest score is 0 and the highest score is 100. Higher scores mean a worse outcome.

  4. Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale

    Time frame: 8 weeks

    The Multiple Sclerosis Walking Scale is a 12-item self-report questionnaire that takes approximately 10 minutes to complete and reflects a persons' perception of the impact that multiple sclerosis has on walking ability during the past 2 weeks. Each of the items scored ranges from 1 to 5, in which higher scores indicate a greater impact of multiple sclerosis on their walking. Scores on the 12 items are summed. To transform to a 0-100 scale, the minimum score of 12 is subtracted from the sum; the result is divided by 48 and then multiplied by 100. The lowest score is 0 and the highest score is 100. Higher scores mean a worse outcome.

  5. Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54

    Time frame: Baseline

    The Multiple Sclerosis Quality of Life-54 is a self-report quality of life questionnaire. It measures health-related quality of life using both generic and disease-specific measures and was constructed by experts in the field. There is no overall score for this scale since it contains 12 subscales, two summary scores, and two single-item measures. The quality of life subscale was the chosen outcome measure reported below. The scores range from 0-100. Higher scores on the scale notes improved outcome.

  6. Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54

    Time frame: 8 weeks

    The Multiple Sclerosis Quality of Life-54 is a self-report quality of life questionnaire. It measures health-related quality of life using both generic and disease-specific measures and was constructed by experts in the field. There is no overall score for this scale since it contains 12 subscales, two summary scores, and two single-item measures. The quality of life subscale was the chosen outcome measure reported below. The scores range from 0-100. Higher scores on the scale notes improved outcome.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study 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

Acronym: MSCycling

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2015
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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