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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RT 300: Lower Extremity Cycling
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Functional Electrical Stimulation, Cycling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stony Brook Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FES Cycling

Cycling Only

Arm 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).

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.

Outcomes

Primary Outcome Measures

Gait Velocity: Timed Walking
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.
Gait Velocity: Timed Walking
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.
Gait Velocity: Timed Walking
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.
Gait Velocity: Timed Walking
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 Outcome Measures

Self-reported Fatigue Using Modified Fatigue Impact Scale
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.
Self-reported Fatigue Using Modified Fatigue Impact Scale
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.
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
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.
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
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.
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
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.
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
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.

Full Information

First Posted
March 19, 2015
Last Updated
September 27, 2019
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT02606604
Brief Title
Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS
Acronym
MSCycling
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Functional Electrical Stimulation, Cycling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES Cycling
Arm Type
Experimental
Arm 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).
Arm Title
Cycling Only
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
RT 300: Lower Extremity Cycling
Other Intervention Name(s)
RT 300, Lower Extremity Ergometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait Velocity: Timed Walking
Description
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.
Time Frame
Baseline
Title
Gait Velocity: Timed Walking
Description
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.
Time Frame
4 weeks
Title
Gait Velocity: Timed Walking
Description
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.
Time Frame
8 weeks
Title
Gait Velocity: Timed Walking
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Self-reported Fatigue Using Modified Fatigue Impact Scale
Description
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.
Time Frame
Baseline
Title
Self-reported Fatigue Using Modified Fatigue Impact Scale
Description
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.
Time Frame
8 weeks
Title
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
Description
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.
Time Frame
Baseline
Title
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
Description
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.
Time Frame
8 weeks
Title
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
Description
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.
Time Frame
Baseline
Title
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori I Hochman, PT, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook Univeristy
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

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

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