Recruiting

Observational Study

Sponsor:

North Carolina State University

Code:

NCT05249595

Conditions

Incomplete Spinal Cord Injury

Transverse Myelitis

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Surface electromypgraphy-based interface to predict human ankle joint motion intent and use in ankle assistive devices

Ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices

Surface electromypgraphy and ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices

Study Details

Brief 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.

Conditions

Incomplete Spinal Cord Injury

Transverse Myelitis

Study ID

NCT05249595

Start date

Feb 10, 2020

Status verified date

Feb, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group A - Particiapnts without neurological disorders

Individuals without neurological disorders will be recruited (Group A).

experimental: Group S - Participants with iSCI or transverse myelitis

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.

Interventions

Surface electromypgraphy-based interface to predict human ankle joint motion intent and use in ankle assistive devices

The study involves the validation of computer algorithms to estimate human ankle joint motion intent and control of ankle joint assistance by using either a powered exoskeleton or an FES system. The ankle joint motions will include seated posture tasks and walking tasks. The instrumented treadmill and Vicon motion capture system will be used to facilitate the cyclic walking pattern and record the participant's kinematics. The human ankle joint volitional effort will be predicted by the sEMG signals from shank muscles. The powered exoskeleton or FES system will provide ankle joint assistance based on an assist-as-needed strategy.

Ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices

The study involves the validation of computer algorithms to estimate human ankle joint motion intent and control of ankle joint assistance by using either a powered exoskeleton or an FES system. The ankle joint motions will include seated posture tasks and walking tasks. The instrumented treadmill and Vicon motion capture system will be used to facilitate the cyclic walking pattern and record the participant's kinematics. The human ankle joint volitional effort will be predicted by the ultrasound imaging signals from shank muscles. The powered exoskeleton or FES system will provide ankle joint assistance based on an assist-as-needed strategy.

Surface electromypgraphy and ultrasound imaging-based interface to predict human ankle joint motion intent and use in ankle assistive devices

The study involves the validation of computer algorithms to estimate human ankle joint motion intent and control of ankle joint assistance by using either a powered exoskeleton or an FES system. The ankle joint motions will include seated posture tasks and walking tasks. The instrumented treadmill and Vicon motion capture system will be used to facilitate the cyclic walking pattern and record the participant's kinematics. The human ankle joint volitional effort will be predicted by combining sEMG and ultrasound imaging signals from shank muscles. The powered exoskeleton or FES system will provide ankle joint assistance based on an assist-as-needed strategy.

Primary outcome measure

  • Human volitional effort [ Time Frame: Through study completion, an average of 40 months. ]
  • Evaluate the controller performance of human ankle joint [ Time Frame: Through study completion, an average of 40 months. ]

Central Contacts and Locations

Central contacts

Nitin Sharma, Ph.D.

919-513-0787nsharm23@ncsu.edu

Locations

1807 N. Fordham Blvd. UNC Center for Rehabilitation Care of Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Christine Cleveland, MD

984-974-9747Christine_Cleveland@med.unc.edu

4212C Engineering Building III 1840 Entrepreneur Dr.

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

Nitin Sharma, PhD

919-513-0787nsharm23@ncsu.edu

More Information

Sponsor

North Carolina State University

Last update posted

Feb 21, 2022

Last verified

Feb, 2022

Keywords

  • Voluntary strength
  • Ankle joint
  • Neuromuscular model
  • Ankle exoskeleton
  • Functional electrical stimulation
  • Nonlinear control
  • Sensor fusion
  • Treadmill walking
  • Walking biomechanics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by North Carolina State University on 2022-02-21.