Clinical trial NCT03403413: Muscle Vibration in MS to Improve Walking
Official title: Cyclical Muscle Vibration in MS to Improve Walking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-01-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: 10MWT
timeFrame: 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.
measure: Kinematics
timeFrame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
measure: Toe Clearance
timeFrame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
measure: Walking Distance
timeFrame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Stephen M. Selkirk, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: