Neurological DisordersNCT04094571
Muscle Delay Characterization
A study testing Functional Electrical Stimulation (FES) Angle Protocol in people with Neurological Disorders, run by University of Florida at 1 site in United States.
Trial summary
Functional electrical stimulation (FES) induced cycling is a common rehabilitative therapy. Closed-loop FES control holds the promise to improve rehabilitation procedures. However, FES results in a delay between the time of stimulation and muscle contraction and rapidly fatigues muscle. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurological Disorders
- What is being tested?
- Functional Electrical Stimulation (FES) Angle Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 3 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy normal individuals aged 18-65 and individuals with movement disorders (e.g., spinal cord injury, Parkinson's disease, stroke)
- capable to perform the cycling exercises either voluntarily or under controlled electrical stimulation
- all participants have to be medically stable (i.e., do not exhibit asymptomatic osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with testing or training)
- for neurologically impaired individuals, they should have a single neurologic condition
- under all situations the body size and weight of participant has to be compatible with the testing apparatus to ensure safety at all times
Who cannot join
- participants who are unresponsive to surface FES are not considered eligible for the study
- a history of significant cardiovascular disorders, chronic arterial diseases or congestive cardiac failure, including being medicated for hypertension and/or have an implanted pacemaker
- have a history of major musculoskeletal problems that limit hip and knee extension such as orthopedic surgery, including ACL reconstruction and/or joint replacements
- participants with denervated muscle, severe osteoporosis or abnormal bone formation in hip/knee joints, bone fractures, acute hernia, severe muscle spasticity, infection in the lower extremities, epilepsy, diabetes, severe angina, pressure ulcers, vein thrombosis, and any ailments causing high fever, high blood pressure or high heart rate
- pregnant women, children/minors, adults with diminished decision-making capacity, and non-English speakers
- under all situations the body size and weight of participant has to be compatible with the testing apparatus to ensure safety at all times
Trial locations and contacts
1 site in 1 country.
United States1 site
NCR lab in MAE-B building at the University of Florida
Gainesville, Florida, 32603
About this study
Official title: Characterizing the Delayed Muscle Response to Electrical Stimulation
Functional electrical stimulation (FES) induced cycling is a common rehabilitative therapy. Closed-loop FES control holds the promise to improve rehabilitation procedures. However, FES results in a delay between the time of stimulation and muscle contraction and rapidly fatigues muscle. The purpose of this study is to measure the FES-induced delay on an FES cycle and to understand how the delay varies as a function of how long the user has been cycling and a function of the crank angle.
Read the detailed description
This study will use non-invasive approaches (surface electrodes, encoders, torque meters, motors) to study muscle delay and how muscle fatigues for both individuals possessing movement disorders and healthy individuals. Individuals with movement disorders are often susceptible to partial or total paralysis. This paralysis often leads to an increasingly sedentary lifestyle. By implementing the intelligent closed-loop control of FES-cycling, FES-therapy can be made more effective, combating the effects of sedentary lifestyles. Using data obtained from non-invasive sensors, the study team will apply analytical techniques to quantify FES muscle delay and how well individuals can track a desired cadence as the muscle fatigues. A challenge associated with FES-induced cycling is that there exists a delay between the time when FES is applied and the time when the muscle contracts. There is likewise a delay between the time FES is removed and the time the muscle ceases to contract. Previous studies have measured this delay and determined that it varies with fatigue. A goal of this project is to measure this delay on an FES-cycle and to determine how this delay varies as a result of FES-induced cycling. Another goal is to determine what effect the crank angle has on the delay as well as on the muscle control effectiveness. This study will provide insight into how engineering can be combined with healthcare and therapy to better both fields and bridge the gap between engineering and medicine.
- Conditions
- Neurological Disorders
- Being tested
- Functional Electrical Stimulation (FES) Control Protocol, Functional Electrical Stimulation (FES) Angle Protocol
- Keywords
- functional electrical stimulation, rehabilitation
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation (FES) Control ProtocolDevice
Also called FES modified TerraTrike Rover recumbent tricycle
To measure the delay, the motor will take the tricycle crank to pre-specified angles and then hold that position while various combinations of the quadriceps femoris and the gluteal muscle groups are stimulated in study participants.
Functional Electrical Stimulation (FES) Angle ProtocolDevice
Also called FES modified TerraTrike Rover recumbent tricycle
To determine the effect of the crank angle on the FES delay and the muscle control effectiveness, the crank is positioned at a pre-specified angle, with various muscle groups being stimulated while holding this position. The motor then takes the crank to another angle and the process is repeated.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals and those with Movement Disorders | Experimental | Participants will perform the FES cycling protocol along with the FES angle protocol. Receives: Device: Functional Electrical Stimulation (FES) Control Protocol; Device: Functional Electrical Stimulation (FES) Angle Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of crank torque
A torque meter (SRM Science PowerMeter) is attached to the tricycle's crank to provide instantaneous feedback of the rider torque. A combination of muscle groups will be stimulated and the resulting crank torque will be measured by the meter.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisordersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Warren Dixon, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094571
- Sponsor's protocol ID
- IRB201901676 -N
- Other IDs
- 1762829
- Status last verified
- Oct 2021
- First submitted
- 17 Sep 2019
- Last updated
- 6 Oct 2021
- 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 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Delayed Muscle Response to Electrical Stimulation
- ClinicalTrials.gov ID
- NCT04094571
- Acronym / sponsor ID
- IRB201901676 -N
- Conditions
- Neurological Disorders
- Keywords
- functional electrical stimulation, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Science Foundation
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 19 Sep 2019 (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.
Functional electrical stimulation (FES) induced cycling is a common rehabilitative therapy. Closed-loop FES control holds the promise to improve rehabilitation procedures. However, FES results in a delay between the time of stimulation and muscle contraction and rapidly fatigues muscle. The purpose of this study is to measure the FES-induced delay on an FES cycle and to understand how the delay varies as a function of how long the user has been cycling and a function of the crank angle.
Detailed description
This study will use non-invasive approaches (surface electrodes, encoders, torque meters, motors) to study muscle delay and how muscle fatigues for both individuals possessing movement disorders and healthy individuals. Individuals with movement disorders are often susceptible to partial or total paralysis. This paralysis often leads to an increasingly sedentary lifestyle. By implementing the intelligent closed-loop control of FES-cycling, FES-therapy can be made more effective, combating the effects of sedentary lifestyles. Using data obtained from non-invasive sensors, the study team will apply analytical techniques to quantify FES muscle delay and how well individuals can track a desired cadence as the muscle fatigues. A challenge associated with FES-induced cycling is that there exists a delay between the time when FES is applied and the time when the muscle contracts. There is likewise a delay between the time FES is removed and the time the muscle ceases to contract. Previous studies have measured this delay and determined that it varies with fatigue. A goal of this project is to measure this delay on an FES-cycle and to determine how this delay varies as a result of FES-induced cycling. Another goal is to determine what effect the crank angle has on the delay as well as on the muscle control effectiveness. This study will provide insight into how engineering can be combined with healthcare and therapy to better both fields and bridge the gap between engineering and medicine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals and those with Movement Disorders | Experimental | Device: Functional Electrical Stimulation (FES) Control Protocol, Device: Functional Electrical Stimulation (FES) Angle ProtocolParticipants will perform the FES cycling protocol along with the FES angle protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy normal individuals aged 18-65 and individuals with movement disorders (e.g., spinal cord injury, Parkinson's disease, stroke)
- capable to perform the cycling exercises either voluntarily or under controlled electrical stimulation
- all participants have to be medically stable (i.e., do not exhibit asymptomatic osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with testing or training)
- for neurologically impaired individuals, they should have a single neurologic condition
- under all situations the body size and weight of participant has to be compatible with the testing apparatus to ensure safety at all times
Key exclusion criteria (6 listed)
- participants who are unresponsive to surface FES are not considered eligible for the study
- a history of significant cardiovascular disorders, chronic arterial diseases or congestive cardiac failure, including being medicated for hypertension and/or have an implanted pacemaker
- have a history of major musculoskeletal problems that limit hip and knee extension such as orthopedic surgery, including ACL reconstruction and/or joint replacements
- participants with denervated muscle, severe osteoporosis or abnormal bone formation in hip/knee joints, bone fractures, acute hernia, severe muscle spasticity, infection in the lower extremities, epilepsy, diabetes, severe angina, pressure ulcers, vein thrombosis, and any ailments causing high fever, high blood pressure or high heart rate
- pregnant women, children/minors, adults with diminished decision-making capacity, and non-English speakers
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 |
|---|---|---|
| Functional Electrical Stimulation (FES) Control ProtocolAlso: FES modified TerraTrike Rover recumbent tricycleTo measure the delay, the motor will take the tricycle crank to pre-specified angles and then hold that position while various combinations of the quadriceps femoris and the gluteal muscle groups are stimulated in study participants. | Device | Healthy Individuals and those with Movement Disorders |
| Functional Electrical Stimulation (FES) Angle ProtocolAlso: FES modified TerraTrike Rover recumbent tricycleTo determine the effect of the crank angle on the FES delay and the muscle control effectiveness, the crank is positioned at a pre-specified angle, with various muscle groups being stimulated while holding this position. The motor then takes the crank to another angle and the process is repeated. | Device | Healthy Individuals and those with Movement Disorders |
Primary outcome
Measure of crank torque
Time frame: Day 1
A torque meter (SRM Science PowerMeter) is attached to the tricycle's crank to provide instantaneous feedback of the rider torque. A combination of muscle groups will be stimulated and the resulting crank torque will be measured by the meter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- 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.
Warren Dixon, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation (FES) Angle Protocol in people with Neurological Disorders, run by University of Florida 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Oct 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of crank torque (time frame: Day 1). 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 6 Oct 2021.