Spinal Cord InjuriesNCT04238013
Neuromodulation of Ankle Muscles in Persons With SCI
A study testing Whole Body Vibration (WBV) and Electrical Stimulation in people with Spinal Cord Injuries and Spastic Gait, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Cord Injuries, Spastic Gait, Foot Drop
- What is being tested?
- Whole Body Vibration (WBV) and Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to 9 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Spastic Gait, Foot Drop
- Being tested
- Whole Body Vibration (WBV), Electrical Stimulation
- Medical subject headings
- Spinal Cord Injuries, Gait Disorders, Neurologic, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Vibration (WBV)Other
The WBV session will consist of 8 bouts of 45s vibration (50Hz) with a minute of rest in between each bout.
Electrical StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Corticospinal Tract Excitability | Active comparator | 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. Receives: Other: Whole Body Vibration (WBV); Other: Electrical Stimulation |
| Spinal Reflex Circuit Excitability | Active comparator | 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. Receives: Other: Whole Body Vibration (WBV); Other: Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volitional Ankle Control-Tapping Task Performance
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.
Measured: Through study completion at 2 weeks
Ankle Spasticity-Ankle Clonus
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.
Measured: Through study completion at 2 weeks
Secondary outcomes (6)
Corticospinal tract excitability-Motor Evoked Potentials
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.
Measured: Through study completion at 2 weeks
Low frequency depression
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.
Measured: Through study completion at 2 weeks
Spinal Cord Assessment Tool for Spastic Reflexes
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.
Measured: Through study completion at 2 weeks
Ankle Isometric Strength Test
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.
Measured: Through study completion at 2 weeks
Walking speed and walking pattern
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).
Measured: Through study completion at 2 weeks
Heart rate and %SpO2
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.
Measured: Through study completion at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start6 Jul 2021
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Why it stopped: Due to the ongoing COVID-19 pandemic, my recruitment progress was delayed to the point that I had to reevaluate the feasibility of continuing data collection.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA
- Investigators
- Edelle Field-Fote, PT, PhD, Principal investigator, Director of Spinal Cord Injury Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238013
- Sponsor's protocol ID
- 777
- Other IDs
- F31HD101151
- Status last verified
- Jun 2022
- First submitted
- 17 Jan 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Whole Body Vibration on Neuromodulation of Ankle Muscles in Persons With SCI
- ClinicalTrials.gov ID
- NCT04238013
- Acronym / sponsor ID
- 777
- Conditions
- Spinal Cord Injuries, Spastic Gait, Foot Drop
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the ongoing COVID-19 pandemic, my recruitment progress was delayed to the point that I had to reevaluate the feasibility of continuing data collection.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticospinal Tract Excitability | Active comparator | Other: Whole Body Vibration (WBV), Other: Electrical StimulationDuring 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. |
| Spinal Reflex Circuit Excitability | Active comparator | Other: Whole Body Vibration (WBV), Other: Electrical StimulationDuring 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Corticospinal Tract Excitability, Spinal Reflex Circuit Excitability |
| Electrical StimulationThe 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. | Other | Corticospinal Tract Excitability, Spinal Reflex Circuit Excitability |
Primary outcome
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.
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.
6 secondary outcomes
Corticospinal tract excitability-Motor Evoked Potentials
Time frame: Through study completion at 2 weeks
Low frequency depression
Time frame: Through study completion at 2 weeks
Spinal Cord Assessment Tool for Spastic Reflexes
Time frame: Through study completion at 2 weeks
Ankle Isometric Strength Test
Time frame: Through study completion at 2 weeks
Walking speed and walking pattern
Time frame: Through study completion at 2 weeks
Heart rate and %SpO2
Time frame: Through study completion at 2 weeks
Results and safety
The study was stopped early (reason given: Due to the ongoing COVID-19 pandemic, my recruitment progress was delayed to the point that I had to reevaluate the feasibility of continuing data collection.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edelle Field-Fote, PT, PhD principal investigator
Director of Spinal Cord Injury Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration (WBV) and Electrical Stimulation in people with Spinal Cord Injuries and Spastic Gait, run by Shepherd Center, Atlanta GA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the ongoing COVID-19 pandemic, my recruitment progress was delayed to the point that I had to reevaluate the feasibility of continuing data collection.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volitional Ankle Control-Tapping Task Performance (time frame: Through study completion at 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.