Muscle Vibration in MS to Improve Walking

April 27, 2020 updated by: VA Office of Research and Development

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • Presence of demand pacemakers.
  • Edema of the affected limb/s.
  • Uncontrolled seizures/epilepsy.
  • Severe depression.
  • Botulin toxin treatment within 12 months.
  • Peripheral neuropathy.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Muscle Vibration
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.
Device: muscle vibration during walking
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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
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
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
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
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
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
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen M. Selkirk, MD PhD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F2177-P
  • RX002177 (OTHER: Louis Stokes VA Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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