Multiple SclerosisMSCyclingNCT02606604
Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS
A study testing RT 300: Lower Extremity Cycling in people with Multiple Sclerosis, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- RT 300: Lower Extremity Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- RT 300: Lower Extremity Cycling
- Keywords
- Functional Electrical Stimulation, Cycling
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT 300: Lower Extremity CyclingDevice
Also called RT 300, Lower Extremity Ergometer
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: RT 300: Lower Extremity Cycling |
| 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. Receives: Device: RT 300: Lower Extremity Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Hochman, Stony Brook University
- Investigators
- Lori I Hochman, PT, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606604
- Sponsor's protocol ID
- 534378-1
- Acronym
- MSCycling
- Status last verified
- Sep 2019
- First submitted
- 19 Mar 2015
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02606604
- Acronym / sponsor ID
- MSCycling / 534378-1
- Conditions
- Multiple Sclerosis
- Keywords
- Functional Electrical Stimulation, Cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES Cycling | Experimental | Device: RT 300: Lower Extremity CyclingThe 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). |
| Cycling Only | Active comparator | Device: RT 300: Lower Extremity CyclingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT 300: Lower Extremity CyclingAlso: RT 300, Lower Extremity ErgometerIndividuals 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. | Device | Cycling Only, FES Cycling |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Self-reported Fatigue Using Modified Fatigue Impact Scale
Time frame: Baseline
Self-reported Fatigue Using Modified Fatigue Impact Scale
Time frame: 8 weeks
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
Time frame: Baseline
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale
Time frame: 8 weeks
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
Time frame: Baseline
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori I Hochman, PT, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT 300: Lower Extremity Cycling in people with Multiple Sclerosis, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Velocity: Timed Walking (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.