Multiple Sclerosis
Conditions
Keywords
Functional Electrical Stimulation, Cycling
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
Interventions
DEVICERT 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.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity: Timed Walking | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Fatigue Using Modified Fatigue Impact Scale | 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. |
| Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale | 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. |
| Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54 | 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. |
Countries
United States
Participant flow
Recruitment details
PWMS were recruited from various sources from including: physician practices, physical therapy practices, support groups, web postings, email, fitness centers, and personal communication. Recruitment was from June 2015 - July 2017.
Pre-assignment details
Participants were excluded from the study if they did not meet the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 7 |
| 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. | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | FES Cycling | Cycling Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 11 Participants |
| Age, Continuous | 59.71 years STANDARD_DEVIATION 7.54 | 47.51 years STANDARD_DEVIATION 8.97 | 53.64 years STANDARD_DEVIATION 10.16 |
| Patient Determined Disease Steps (PPDS) | 3.71 units on a scale STANDARD_DEVIATION 0.76 | 3.71 units on a scale STANDARD_DEVIATION 1.11 | 3.71 units on a scale STANDARD_DEVIATION 0.91 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Gait Velocity: Timed Walking | 1.33 meters/second | Standard Error 1.39 |
| Cycling Only | Gait Velocity: Timed Walking | 1.4 meters/second | Standard Error 1.48 |
Primary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Gait Velocity: Timed Walking | 1.39 meters/second | Standard Error 0.18 |
| Cycling Only | Gait Velocity: Timed Walking | 1.45 meters/second | Standard Error 0.18 |
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Gait Velocity: Timed Walking | 1.44 meters/second | Standard Error 0.18 |
| Cycling Only | Gait Velocity: Timed Walking | 1.42 meters/second | Standard Error 0.18 |
Primary
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Gait Velocity: Timed Walking | 1.34 meters/second | Standard Error 0.18 |
| Cycling Only | Gait Velocity: Timed Walking | 1.42 meters/second | Standard Error 0.18 |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54 | 70.95 score on a scale | Standard Error 6.28 |
| Cycling Only | Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54 | 60.95 score on a scale | Standard Error 6.28 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54 | 61.19 score on a scale | Standard Error 6.28 |
| Cycling Only | Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54 | 57.62 score on a scale | Standard Error 6.28 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Self-reported Fatigue Using Modified Fatigue Impact Scale | 42 score on a scale | Standard Error 6.19 |
| Cycling Only | Self-reported Fatigue Using Modified Fatigue Impact Scale | 47.13 score on a scale | Standard Error 6.19 |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Self-reported Fatigue Using Modified Fatigue Impact Scale | 32 score on a scale | Standard Error 6.19 |
| Cycling Only | Self-reported Fatigue Using Modified Fatigue Impact Scale | 39.57 score on a scale | Standard Error 6.19 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale | 64.43 score on a scale | Standard Error 6.78 |
| Cycling Only | Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale | 71.43 score on a scale | Standard Error 6.78 |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycling | Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale | 59.91 score on a scale | Standard Error 6.68 |
| Cycling Only | Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale | 69.52 score on a scale | Standard Error 6.78 |