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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES Cycling | Experimental | 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). |
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| Cycling Only | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 4 weeks |
| 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. | 8 weeks |
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori I Hochman, PT, PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook Univeristy | Stony Brook | New York | 11794 | United States |
Participants were excluded from the study if they did not meet the inclusion/exclusion criteria.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Electrical Stimulation Cycling | The intervention consisted 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 for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. |
| FG001 | Cycling Only | The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Seven subjects completed this arm of the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | meters/second | Baseline |
|
Up to 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Hochman | Stony Brook University | 631-444-1193 | lori.hochman@stonybrook.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2016 | Sep 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Baseline |
| 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. | 8 weeks |
| 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. | Baseline |
| 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. | 8 weeks |
| 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. | Baseline |
| 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. | 8 weeks |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patient Determined Disease Steps (PPDS) | PPDS is a self-report measure that determines level of disability and disease stage of people with multiple sclerosis. This scale ranges from 0 to 8, with 0 = no disability and 8 = bed-ridden. | Mean | Standard Deviation | units on a scale |
|
| Cycling Only |
The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention. |
|
|
| 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. | Posted | Mean | Standard Error | meters/second | 4 weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | meters/second | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | meters/second | 12 weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 8 weeks |
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|
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| 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. | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 8 weeks |
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|
|
| 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. | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 8 weeks |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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. 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. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |