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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT04149769
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older.
* Size and limb proportions capable of fitting in the exoskeletal device :
* Height between 1.55 m (5 ft, 1 in) and 1.92 m (6 ft, 3 in).
* Femur length between 37.5 cm (15 in) and 43.125 cm (17.25 in).
* Body mass no greater than 114 kg (250 lb).
* "Poorly ambulatory" individual, defined as a person with FIM Gait 2- 6, who may be able to walk short distances with or without braces or stability aid, or may be able to walk with assistance of one person, but whose primary means of mobility is a manual or power-operated wheelchair.
* Sufficient upper extremity strength and coordination to balance using appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
* Neurological injury level (NLI) T3 to L5 (between and inclusive).
* Chronic SCI: at least 6 months post-injury, and preferably post-injury more than 1 year.
* Sufficient bone health for walking with full weight-bearing without undue risk of fracture, as determined by each subject's personal medical doctor, and approved by each site's medical supervisor.
* Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid.
* Skin intact where interfacing with robotic device.
* MAS for spasticity score 3 or less in lower extremities.
* Resting blood pressure and heart rate within established guidelines for locomotor training, specifically systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less.
* Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.
* Availability and willingness of support person to be trained in accordance with the FDA training protocol for personal use of the exoskeleton, and who will assume responsibility for the support person role, which specifically includes providing ambulatory support during all exoskeletal walking.
* Access to a wireless internet connection (for use of exoskeleton iPod device).
* Willingness and ability to electronically send walking session reports from exoskeleton iPod to appointed site monitor following each walking session.
Exclusion Criteria:
* Heterotopic ossification that, in the opinion of the site medical supervisor, would place the subject at undue risk for fracture.
* Inability to follow instructions.
* Colostomy bag.
* Women who are pregnant or attempting to become pregnant during the course of the study. Note that a pregnancy test will be required and must be negative for all women prior to enrolling in the study, and will be additionally required and must be negative every four weeks during the course of the study protocol.
* Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments.
* Insufficient availability to complete study.
* Any other issue which, in the opinion of the investigators or medical supervisor, make the subject unsuitable for study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04149769
Study Brief:
Protocol Section:
NCT04149769