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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03403413
Study type Interventional
Source VA Office of Research and Development
Contact
Status Terminated
Phase N/A
Start date January 1, 2017
Completion date December 31, 2018

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