Muscle Vibration in MS to Improve Walking



Status:Active, not recruiting
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:1/13/2019
Start Date:January 1, 2017
End Date:September 30, 2019

Use our guide to learn which trials are right for you!

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).

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.

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
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Stephen M. Selkirk, MD PhD
Phone: 216-791-3800
?
mi
from
Cleveland, OH
Click here to add this to my saved trials