Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT05249595
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05249595
Study Brief:
Protocol Section:
NCT05249595