Exoskeleton-Assisted Walking ExoAtlet II

Craig Hospital

Status

Withdrawn

Conditions

Spinal Cord Injuries

Treatments

Device: ExoAtlet II

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04532723

IRBNet ID 1559813

Details and patient eligibility

About

Based on prior exoskeleton research, it was determined that 40 participants of variable height, weight and injury level would provide a significant measure of the safety and feasibility of using the ExoAtlet II in individuals with SCI for standing and walking rehabilitation therapy. Craig Hospital will be responsible for enrolling up to 30 individuals during the study duration.The inclusion criteria will be utilized to identify appropriate subjects for this study.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Spinal Cord injury with lower extremity paralysis (partial or complete) levels T4-L5 (AIS A-C) or C7-T3 (AIS D)
18 Years of age or older in general good health
Weight, no more than 220lbs (100kg)
Intact Skin
Able to stand without exhibiting symptomatic hypotension
Use a wheelchair for mobility at least 50% of the day
Enough strength in hands and shoulders to support standing and walking using crutches or a walker
Medical clearance for full weight-bearing

---Per our clinical guidelines, we will require all individuals with SCI who are going to use an exoskeleton to receive full weight-bearing medical clearance from their physician prior to participation. If they are unable to obtain full weight-bearing medical clearance they will not be able to participate in this study.
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
Hip width no greater than 18" (46 cm) measured when sitting
Femur length between 37 cm and 49 cm measured between mid-patellar tendon and the floor

Exclusion criteria

Spinal cord injury level higher than T4 (AIS A-C) or C7 ASIA D
Severe muscle stiffness/tightness
Significant spasticity (Modified Ashworth Scale score of 3 or above)
Trunk or lower extremity pressure wound
Unstable spine, un-healed limbs, or fractures
Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints

---Each individual who is interested in participating in this study will be screened for heterotropic ossification (HO) using a verbal checklist first and then they participate in a thorough range of motion (ROM) evaluation before being fit in the exoskeleton. If they verbalize a history of HO or demonstrate a bony block/resistance to passive ROM, they will be sent back to their physician to rule out HO and will not participate in the study until they receive additional clearance.
Joint instability, dislocation, moderate to severe hip dysplasia
Uncontrolled seizures
Fracture or lower-limb surgery in past year
Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton
Pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).