Neuromodulation of Ankle Muscles in Persons With SCI

June 21, 2022 updated by: Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA

Influence of Whole Body Vibration on Neuromodulation of Ankle Muscles in Persons With SCI

The ability to voluntarily move the ankles is important for walking. After spinal cord injury (SCI), this ability is impaired because of changes in the communication between the brain, spinal cord, and body. Whole body vibration (WBV) is a treatment that increases voluntary muscle control and decreases uncontrollable muscle movement in people with SCI. The purpose of this study is to understand how WBV can impact ankle control and uncontrollable muscle movement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Spinal cord injury can result in impaired walking ability and decreased independence in daily activities such as standing and transfers. The ability to voluntarily control the ankle muscles is an important component of walking that is impacted by changes in the corticospinal tract and the spinal reflex circuits. These changes have been associated with the inability to dorsiflex the ankle during swing phase (foot drop) and uncontrollable muscle spasms and stiffness in the ankle during terminal stance (spasticity), as well as during transfers. In order to improve functional outcomes and further develop rehabilitation techniques, the underlying contributions of the corticospinal tract and spinal reflex circuit to ankle control needs to be better understood. Non-invasive tools that target the corticospinal and spinal reflex circuit are being used in clinical settings in order to improve functional outcomes in persons with spinal cord injury. Whole body vibration (WBV) is a non-invasive tool that has been shown to increase voluntary motor output and decrease spasticity in persons with spinal cord injury. These improvements in function may be due to changes in the corticospinal tract and spinal reflex circuits. In order to determine the relative contributions of the corticospinal tract and spinal reflex circuits to increased voluntary ankle control and decreased spasticity, we will measure changes in the corticospinal tract and spinal reflex excitability before and after a single session of vibration. We will then determine which change (corticospinal or spinal) contributes more to increased voluntary ankle control and decreased spasticity. This information will help guide future research to further improve walking ability in persons with spinal cord injury.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability and willingness to consent and authorize use of Protected Health Information (PHI)
  • Be between 18-85 years of age
  • Be able to provide a letter of medical clearance for participation, if 70-85 years of age
  • Have a SCI level of T12 of above, occurring more than 6 months ago
  • Have a motor-incomplete severity classification (AIS C OR D)
  • Have self-reported spasticity in at least one ankle
  • Have a score of at least 2 indicating at least moderate spasticity on the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) clonus test in at least one ankle
  • Have the ability to voluntarily move at least one ankle
  • Must be able to stand and take at least 4 steps with or without assistive devices

Exclusion Criteria:

  • Implanted metallic device in the head and/ or pacemaker
  • Use of ankle-foot orthoses
  • History of seizures
  • History of frequent and/ or severe headaches
  • Prior tendon or nerve transfer surgery
  • Current pregnancy
  • Inability or unwillingness to consent and Authorization for use of PHI
  • Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
  • Neurologic level below spinal level T12
  • History of cardiovascular irregularities
  • Problems with following instructions
  • Orthopedic problems that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees).
  • Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Corticospinal Tract Excitability
During the Corticospinal Tract Excitability arm, corticospinal excitability will be assessed by measuring motor evoked potentials after transcranial magnetic stimulation pre-post each intervention in conjunction with other outcome measures.
Other: Whole Body Vibration (WBV)
The WBV session will consist of 8 bouts of 45s vibration (50Hz) with a minute of rest in between each bout.
Other: Electrical Stimulation
The electrical stimulation intervention serves to account for any effects of standing and/or of repeated performance of the sit-to-stand behavior on neurophysiological outcomes. In the electrical stimulation intervention, participants will receive electrical stimulation while standing on the vibration platform for 8 bouts for 45s with a minute of rest in between without vibration.
ACTIVE_COMPARATOR: Spinal Reflex Circuit Excitability
During the Spinal Reflex Circuit Excitability arm, spinal reflex circuit excitability will be assessed by measuring low frequency depression after Hoffmann-Reflex testing pre-post each intervention in conjunction with other outcome measures.
Other: Whole Body Vibration (WBV)
The WBV session will consist of 8 bouts of 45s vibration (50Hz) with a minute of rest in between each bout.
Other: Electrical Stimulation
The electrical stimulation intervention serves to account for any effects of standing and/or of repeated performance of the sit-to-stand behavior on neurophysiological outcomes. In the electrical stimulation intervention, participants will receive electrical stimulation while standing on the vibration platform for 8 bouts for 45s with a minute of rest in between without vibration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volitional Ankle Control-Tapping Task Performance
Time Frame: Through study completion at 2 weeks
The participant will be seated with the foot positioned on a pressure sensitive switch embedded in a platform. Participants will be asked to voluntarily contract and relax the muscles that lift the front of the foot (while the heel stays in place on the platform) as quickly as possible for 10s for 4 trials with a 60s rest in between.
Through study completion at 2 weeks
Ankle Spasticity-Ankle Clonus
Time Frame: Through study completion at 2 weeks
This test measures the amount of spasticity in the ankle. Motion sensors to record the ankle joint angles will be used. For this test participants will sit upright. The leg will be raised and released allowing the front of the foot to land on the edge of a platform. The angle of the ankle and movement of the foot will be recorded as it drops and catches on the platform.
Through study completion at 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corticospinal tract excitability-Motor Evoked Potentials
Time Frame: Through study completion at 2 weeks
This is a test to evaluate the connection between the brain and spinal cord. The skin over the muscles of the leg will be cleaned with an alcohol swab and a mildly abrasive paste (similar to the feel of toothpaste). Sensors that detect muscle activity will be placed over these sites. The location of these sensors will be marked on the skin at the beginning of each session using a non-toxic cosmetic pencil. Pulses of stimulation will be applied to the head using a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). The strength of the stimulation will be increased until it causes the muscles of the leg to twitch, and the size of the muscle response will be recorded with the sensors placed over the muscles.
Through study completion at 2 weeks
Low frequency depression
Time Frame: Through study completion at 2 weeks
This test measures how the spinal cord responds to brief pulses of stimulation to the nerves of the legs. Recording electrodes will be taped to the muscles of the legs and brief pulses of stimulation will be applied to the legs.
Through study completion at 2 weeks
Spinal Cord Assessment Tool for Spastic Reflexes
Time Frame: Through study completion at 2 weeks
This test measures the amount of spasticity in the legs. A clinician will perform a series of 3 short tests commonly performed in the clinic to test the spasticity in the legs.
Through study completion at 2 weeks
Ankle Isometric Strength Test
Time Frame: Through study completion at 2 weeks
Test measures how strong the ankle muscles are. Participants will sit in a chair with foot pressed against a device that measures force. Participants will be asked to lift the front of the foot against the device as hard as possible.
Through study completion at 2 weeks
Walking speed and walking pattern
Time Frame: Through study completion at 2 weeks
This test measures how fast participants walk and the way the legs move during walking. Participants will wear sensors that track the position of the legs as they walk across the floor. They will be able to use whatever assistive devices they typically use (e.g., lower extremity orthotics, walker, forearm crutches).
Through study completion at 2 weeks
Heart rate and %SpO2
Time Frame: Through study completion at 2 weeks
This test measures the heart rate of participants and the amount of oxygen in the blood. These 2 measures will be taken by placing a sensor on the finger, before and after each intervention.
Through study completion at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shepherd Center, Atlanta GA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edelle Field-Fote, PT, PhD, Director of Spinal Cord Injury Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 777
  • F31HD101151 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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