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You can access this

clinical trial

if you have

Multiple Sclerosis

and you are

between 18 and 70

years old

Phase

The phase for this study is not defined.

Show me locations

The purpose

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).

Provided treatments

Device: muscle vibration during walking

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Locations near you

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Full eligibility criteria for NCT03403413

Ages eligible for Study	18 Years to 70 Years
Genders eligible for Study	All
Accepts Healthy Volunteers	no

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

All locations for NCT03403413

1 locations

United States (1)

Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Not specified

Trial results for NCT03403413

Participant Flow: Overall Study

Muscle Vibration

3 / 5

Completed / Started

Serious Adverse Events

Feasibility

0 / 10

Affected / At Risk

Other Adverse Events

Feasibility

0 / 5

Affected / At Risk

All Locations

View full eligibility

Results

Tris trial is registered with FDA with number: NCT03403413. The sponsor of the trial is VA Office of Research and Development and it is looking for 5 volunteers for the current phase.

Official trial title:
Cyclical Muscle Vibration in MS to Improve Walking

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Trial details

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