Multiple SclerosisNCT03403413
Muscle Vibration in MS to Improve Walking
A study testing muscle vibration during walking in people with Multiple Sclerosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The primary goal of this pilot study is to explore the feasibility of cyclic vibration (CV) of the lower extremity muscles to improve walking in individuals with gait deficits from multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- muscle vibration during walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 Dec 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MS diagnosis reviewed and confirmed by neurologist per the revised McDonald criteria [ ]
- EDDS>3
- Age 18-70
- Fixed gait deficiency defined as being present for at least 3 months without improvement
- Hip, knee and ankle muscle weakness or increased extensor tone with difficulty to initiate a step
- Ability to ambulate at least 10ft with contact guard.
Show all 14Show fewer
- Muscle vibration without untoward sensation.
- Sufficient upper extremity function to use walking aids (walkers, crutches, canes).
- Poor hip-knee-ankle coordination during swing
- Hip, knee and ankle joint range within normal limits.
- Ability to clearly understand written and oral direction in English to provide consent.
- BMI < 30
- Absence of psychological and cognitive problems or chemical dependency
- No acute orthopedic or medical complications
Who cannot join
- Presence of demand pacemakers.
- Edema of the affected limb/s.
- Uncontrolled seizures/epilepsy.
- Severe depression.
- Botulin toxin treatment within 12 months.
- Peripheral neuropathy.
Show all 16Show fewer
- Respiratory disease.
- Chronic pain.
- Rapidly progressive course suggestive of Marburg variant, Hurst encephalomyelitis or PPMS with three or more system involvement.
- Concurrent treatment with Tysabri.
- Cardiac arrhythmias with associated hemodynamic instability.
- Lower extremity injuries that limit range of motion or function
- Joint problems (hip or leg) that limit range of motion or cause pain with movement
- Women during pregnancy
- Patients with a relapse in the 3 months prior to presentation for study evaluation
- Patients with more than two relapses within the past 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
Official title: Cyclical Muscle Vibration in MS to Improve Walking
The primary goal of this pilot study is to explore the feasibility of cyclic vibration (CV) of the lower extremity muscles to improve walking in individuals with gait deficits from multiple sclerosis (MS).
Read the detailed description
This pilot study is designed to test the efficacy and safety of vibration at correcting the typical gait deficits that involve strength and coordination of multiple joints (hip, knee and ankle) in pre- and early swing phases of the gait cycle.
Aim 1: Develop a real-time control algorithm, timed by sensor detected gait events, to provide vibration emulating electromyographic (EMG) activity of target muscles during normal gait and verify its functionality in an able-body volunteer. Further, recruit 12 subjects (6 for CV and 6 controls) with gait deficits at the hip, knee and ankle from MS. Impose vibration during the gait cycle so that it emulates muscle activity pattern of normal gait. Perform baseline quantitative gait analyses to determine the spatio-temporal parameters, foot-to-floor clearance, kinematics, kinetics and patterns of EMG activity during walking with and without vibration in treatment group and without vibration in control group.
Aim 2: Implement 12 sessions (3/week for a month) of gait training with cyclic vibration emulating normal muscle activity of lower extremities in treatment group and gait training without vibration in control group and repeat baseline gait assessment to test the following hypotheses.
Hypothesis 1. Vibration of hip, knee and ankle muscles improves walking speed and foot-to-floor clearance through increased hip and knee pre-swing flexion and improved hip-knee coordination.
Hypothesis 2. Gait training with cyclic muscle vibration induces carryover effects that maintain improved walking after vibration is discontinued.
Hypothesis 3. Muscle vibration produces no untoward sensations or adverse physiological responses.
- Conditions
- Multiple Sclerosis
- Being tested
- muscle vibration during walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle vibration during walkingDevice
Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities in treatment group. Gait assessment both with and without muscle vibration were collected at follow-up after 12 sessions of gait training with muscle vibration.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Vibration | Experimental | Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion. Receives: Device: muscle vibration during walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
10MWT
speed (m/s)
Measured: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Outcome measures were tested both with and without muscle vibration and repeated measures were collected and averaged.
Kinematics
Peak hip, knee and ankle flexion during swing
Measured: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Toe Clearance
Toe clearance between foot and the ground during swing
Measured: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Walking Distance
Volitional walking distance at baseline and after gait training with vibration
Measured: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Funding ran out
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.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephen M. Selkirk, MD PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403413
- Sponsor's protocol ID
- F2177-P
- Other IDs
- RX002177
- Status last verified
- Apr 2020
- First submitted
- 14 Dec 2017
- Last updated
- 8 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclical Muscle Vibration in MS to Improve Walking
- ClinicalTrials.gov ID
- NCT03403413
- Acronym / sponsor ID
- F2177-P
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ran out
- Enrolment
- 5 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 8 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this pilot study is to explore the feasibility of cyclic vibration (CV) of the lower extremity muscles to improve walking in individuals with gait deficits from multiple sclerosis (MS).
Detailed description
This pilot study is designed to test the efficacy and safety of vibration at correcting the typical gait deficits that involve strength and coordination of multiple joints (hip, knee and ankle) in pre- and early swing phases of the gait cycle.
Aim 1: Develop a real-time control algorithm, timed by sensor detected gait events, to provide vibration emulating electromyographic (EMG) activity of target muscles during normal gait and verify its functionality in an able-body volunteer. Further, recruit 12 subjects (6 for CV and 6 controls) with gait deficits at the hip, knee and ankle from MS. Impose vibration during the gait cycle so that it emulates muscle activity pattern of normal gait. Perform baseline quantitative gait analyses to determine the spatio-temporal parameters, foot-to-floor clearance, kinematics, kinetics and patterns of EMG activity during walking with and without vibration in treatment group and without vibration in control group.
Aim 2: Implement 12 sessions (3/week for a month) of gait training with cyclic vibration emulating normal muscle activity of lower extremities in treatment group and gait training without vibration in control group and repeat baseline gait assessment to test the following hypotheses.
Hypothesis 1. Vibration of hip, knee and ankle muscles improves walking speed and foot-to-floor clearance through increased hip and knee pre-swing flexion and improved hip-knee coordination.
Hypothesis 2. Gait training with cyclic muscle vibration induces carryover effects that maintain improved walking after vibration is discontinued.
Hypothesis 3. Muscle vibration produces no untoward sensations or adverse physiological responses.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle Vibration | Experimental | Device: muscle vibration during walkingTest feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- MS diagnosis reviewed and confirmed by neurologist per the revised McDonald criteria [ ]
- EDDS>3
- Age 18-70
- Fixed gait deficiency defined as being present for at least 3 months without improvement
- Hip, knee and ankle muscle weakness or increased extensor tone with difficulty to initiate a step
Key exclusion criteria (16 listed)
- Presence of demand pacemakers.
- Edema of the affected limb/s.
- Uncontrolled seizures/epilepsy.
- Severe depression.
- Botulin toxin treatment within 12 months.
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 |
|---|---|---|
| muscle vibration during walkingBaseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities in treatment group. Gait assessment both with and without muscle vibration were collected at follow-up after 12 sessions of gait training with muscle vibration. | Device | Muscle Vibration |
Primary outcome
10MWT
Time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Outcome measures were tested both with and without muscle vibration and repeated measures were collected and averaged.
speed (m/s)
Kinematics
Time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Peak hip, knee and ankle flexion during swing
Toe Clearance
Time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Toe clearance between foot and the ground during swing
Walking Distance
Time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Volitional walking distance at baseline and after gait training with vibration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
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.
Stephen M. Selkirk, MD PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle vibration during walking in people with Multiple Sclerosis, run by VA Office of Research and Development 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 14 inclusion and 16 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: stopped early, as of the sponsor's last update on 8 May 2020. 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 8 May 2020). 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?
10MWT (time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Outcome measures were tested both with and without muscle vibration and repeated measures were collected and averaged.). 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 8 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.