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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT06169657
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years old, inclusive
* Medical clearance from primary medical team (signed Medical Clearance form)
* Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
* Gait speed between 0-0.79 m/s
* Informed consent provided by participant or POA
* English speaking
Additional Inclusion Criteria for patients post-stroke:
* First stroke, ischemic or hemorrhagic, within the past six months
* Unilateral, supratentorial stroke
Additional Inclusion Criteria for patients iSCI:
* ASIA C or D
* Traumatic iSCI, within past six months
Exclusion Criteria
* Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
* History of or concurrent neurologic condition (i.e., stroke, SCI, PD, TBI, MS, etc.)
* History of peripheral nerve injury
* Severe knee, hip, or ankle osteoarthritis
* Severe osteoporosis as indicated by physician medical clearance
* Open wounds on skin surfaces in contact with exoskeleton or harness
* Unstable spine or unhealed fractures
* Weight bearing precautions
* Unresolved deep vein thrombosis (DVT)
* Pregnancy
* Prisoners
Additional Exclusion criteria for EksoNR13:
* Weight \>220 lbs (100 kg)
* Height below 60 inches or above 76 inches
* Standing hip width of approximately 18 inches or more
* Joint contractures or range of motion deficits that limit normal range of motion during ambulation:
* Knee flexion contracture greater than 12°
* Hip flexion contracture greater than 17°
* Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12°
* Bilateral hip flexion less than 110°
* Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
* Leg length discrepancy:
* Greater than 0.5 in. (1.27 cm) for upper legs
* Greater than 0.75 in. (1.91 cm) for lower legs
* Active heterotopic ossification
* Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
* High anxiety or claustrophobia
* Clostridium difficile or other gastrointestinal isolation precautions
* Colostomy
* Uncontrolled autonomic dysreflexia
* Lower limb prosthesis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06169657
Study Brief:
Protocol Section:
NCT06169657