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Muscle Vibration in MS to Improve Walking

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
muscle vibration during walking
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muscle Vibration

Arm Description

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.

Outcomes

Primary Outcome Measures

10MWT
speed (m/s)
Kinematics
Peak hip, knee and ankle flexion during swing
Toe Clearance
Toe clearance between foot and the ground during swing
Walking Distance
Volitional walking distance at baseline and after gait training with vibration

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
April 27, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03403413
Brief Title
Muscle Vibration in MS to Improve Walking
Official Title
Cyclical Muscle Vibration in MS to Improve Walking
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding ran out
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle Vibration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
muscle vibration during walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
10MWT
Description
speed (m/s)
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.
Title
Kinematics
Description
Peak hip, knee and ankle flexion during swing
Time Frame
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Title
Toe Clearance
Description
Toe clearance between foot and the ground during swing
Time Frame
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Title
Walking Distance
Description
Volitional walking distance at baseline and after gait training with vibration
Time Frame
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M. Selkirk, MD PhD
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Muscle Vibration in MS to Improve Walking

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