Status:
TERMINATED
Muscle Vibration in MS to Improve Walking
Lead Sponsor:
VA Office of Research and Development
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03403413
Start Date
January 1 2017
End Date
December 31 2018
Last Update
May 8 2020
Active Locations (1)
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1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106