UnknownNot Applicable

Ultrasound Imaging Based Sensing of Human Ankle Motion Intent and Control Strategies for Ankle Assistance

United States25 participantsStarted 2020-02-10

Plain-language summary

Robotic therapies aim to improve limb function in individuals with neurological injury. Modulation of robotic assistance in many of these therapies is achieved by measuring the extant volitional strength of limb muscles. However, current sensing techniques, such as electromyography, are often unable to correctly measure the voluntary strength of a targeted muscle. The difficulty is due to their inability to remove ambiguity caused by interference from activities of neighboring muscles. These discrepancies in the measurement can cause the robot to provide inadequate assistance or over-assistance. Improper robotic assistance slows function recovery, and can potentially lead to falls during robot-assisted walking. An ultrasound imaging approach is an alternative voluntary strength detection methodology, which can allow direct visualization and measurement of muscle contraction activities. The aim is to formulate an electromyography-ultrasound imaging-based technique to sense residual voluntary strength in ankle muscles for individuals with neuromuscular disorders. The estimated voluntary strength will be involved in the advanced controller's design of robotic rehabilitative devices, including powered ankle exoskeleton and functional electrical stimulation system. It is hypothesized that the ankle joint voluntary strength will be estimated more accurately by using the proposed electromyography-ultrasound imaging-based technique. And this will help the robotic rehabilitative devices achieve a more adaptive and efficient assistance control, and maximize the ankle joint rehabilitation training benefits.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for participants without neurological disorders: * Age between the ages of 18 and 64, * Weight less than 220 lb, * Able to perform ankle movements such as ankle up motion, ankle down motion, side motion towards inside, and side motion towards outside while seated, and * Able to walk normally at a preferred speed without any assistive device. Exclusion Criteria for participants without neurological disorders: * Any difficulty or an orthopedic condition that would impede ankle movements such as ankle up motion, ankle down motion, side motion towards inside, and side motion towards outside, * Any difficulty walking normally or without assistance, * Absence of sensation in lower extremities, * An allergy to adhesive skin tapes and/or US gels, * Pregnant Females, * No ankle muscle response to FES. Inclusion Criteria for participants with neurological disorders: * 18-64 years of age and have a primary diagnosis of traumatic/non-traumatic iSCI or demyelinating diseases like transverse myelitis, * Weight less than 220 lb, * Sub-acute or chronic phase (at least 3 months after injury) incomplete motor lesion (AIS C or D at enrollment) at cervical, thoracic or lumbar level, * Ability to ambulate over ground independent using either a cane or rolling walker, as well as those that do not require any assistive devices but do have some mobility difficulties, * Medically stable with medical clearance for participation, no evidence of cardiopulmonary or pulmonary disea…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Human volitional effort

Timeframe: Through study completion, an average of 40 months.

Evaluate the controller performance of human ankle joint

Timeframe: Through study completion, an average of 40 months.

Trial details

NCT IDNCT05249595

SponsorNorth Carolina State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Nitin Sharma, Ph.D.

919-513-0787 nsharm23@ncsu.edu

View on ClinicalTrials.gov More Incomplete Spinal Cord Injury trials