Muscle Vibration in MS to Improve Walking

NCT ID: NCT03403413

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Muscle Vibration

Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.

Group Type: EXPERIMENTAL

muscle vibration during walking

Intervention Type: DEVICE

Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities in treatment group. Gait assessment both with and without muscle vibration were collected at follow-up after 12 sessions of gait training with muscle vibration.

Interventions

muscle vibration during walking

Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities in treatment group. Gait assessment both with and without muscle vibration were collected at follow-up after 12 sessions of gait training with muscle vibration.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen M. Selkirk, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RX002177

Identifier Type: OTHER

Identifier Source: secondary_id

F2177-P

Identifier Type: -

Identifier Source: org_study_id