Clinical trial · Interventional
Ultrasound Imaging Based Sensing of Human Ankle Motion Intent and Control Strategies for Ankle Assistance
Ultrasound Imaging Based Sensing to Predict Human Ankle Movement Intent and Assist-As-Needed Control Using Functional Electrical Stimulation and Powered Ankle Exoskeleton
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Incomplete Spinal Cord Injury | — | UNRESOLVED | — |
| Transverse Myelitis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surface electromypgraphy and ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices | Device | — | UNRESOLVED |
| Surface electromypgraphy-based interface to predict human ankle joint motion intent and use in ankle assistive devices | Device | — | UNRESOLVED |
| Ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A - Particiapnts without neurological disorders
- description
- Individuals without neurological disorders will be recruited (Group A).
- interventionNames
- Device: Surface electromypgraphy-based interface to predict human ankle joint motion intent and use in ankle assistive devices
- Device: Ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices
- Device: Surface electromypgraphy and ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices
- type
- EXPERIMENTAL
- label
- Group S - Participants with iSCI or transverse myelitis
- description
- Individuals with neurological disorders, like iSCI or transverse myelitis, will be recruited (Group S). These individuals usually have weakened ankle joint functionalities but can walk independently.
- interventionNames
- Device: Surface electromypgraphy-based interface to predict human ankle joint motion intent and use in ankle assistive devices
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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 disease, severe spasticity, and asymmetric hip positions, * Ability to respond to FES on dorsiflexors and plantarflexors, and * No use of any FES devices or already in use of a FES device for mobility support (like a Bioness device) but will not use the device during the study. Exclusion Criteria for participants with neurological disorders: * Subjects with other neuromuscular diseases such as polio, stroke, or multiple sclerosis, * Presence of transmissible diseases such as (but not limited to) hepatitis or immunodeficiency virus, * Any clinical condition contraindicating gait, * Untreatable chronic pain, * Severe spasticity (Ashworth scale score \> 3), * Severe reduction in lower limb joint Range of Motion (ROM) higher than 20 deg, * At a high risk of a fracture from osteoporosis, * Any skin problem inhibiting robot usage, major depression or psychosis, * Subjects with heart conditions and pacemakers, * Concurrent severe medical disease, pressure sores, open wounds, existing infection, unstable spine, unhealed limber pelvic fractures, history of recurrent fractures, known orthopedic injury to lower extremities, and osteoporosis, * Have open wounds, * Pregnant Females, * No ankle muscle response to FES.
References
Publications (4)
- BACKGROUNDZhang Q, Kim K, Sharma N. Prediction of Ankle Dorsiflexion Moment by Combined Ultrasound Sonography and Electromyography. IEEE Trans Neural Syst Rehabil Eng. 2020 Jan;28(1):318-327. doi: 10.1109/TNSRE.2019.2953588. Epub 2019 Nov 14. PMID 31725385
- BACKGROUNDZhang Q, Iyer A, Kim K, Sharma N. Evaluation of Non-Invasive Ankle Joint Effort Prediction Methods for Use in Neurorehabilitation Using Electromyography and Ultrasound Imaging. IEEE Trans Biomed Eng. 2021 Mar;68(3):1044-1055. doi: 10.1109/TBME.2020.3014861. Epub 2021 Feb 18. PMID 32759078
- BACKGROUNDZhang Q, Iyer A, Sun Z, Kim K, Sharma N. A Dual-Modal Approach Using Electromyography and Sonomyography Improves Prediction of Dynamic Ankle Movement: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2021;29:1944-1954. doi: 10.1109/TNSRE.2021.3106900. Epub 2021 Sep 27. PMID 34428143
- BACKGROUNDZhang Q, Sheng Z, Moore-Clingenpeel F, Kim K, Sharma N. Ankle Dorsiflexion Strength Monitoring by Combining Sonomyography and Electromyography. IEEE Int Conf Rehabil Robot. 2019 Jun;2019:240-245. doi: 10.1109/ICORR.2019.8779530. PMID 31374636