Inclusion and exclusion criteria
flexion knee contractures, neurological injury, traumatic motor complete SCI, scoliosis, areflexia, fracture, contracture, −3.5, ’ knee extensors, cardiovascular problems, Spinal Injury, cauda equina
UNCONTROLLED HYPERTENSION, TYPE II DIABETES MELLITUS, CARDIOVASCULAR DISEASE, SCOLIOSIS, ORTHOSTATIC HYPOTENSION, URINARY TRACT INFECTION
Participants may be included if they are between 18 and 60 years old, male or female, with traumatic motor complete SCI and level of injury of between C5 to T10, as determined the International Standards for Neurological Classification of SCI (ISNCSCI) exam. Participants’ knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration: 450 µs and amplitude of the current: up to 200 mA) to ensure intact neural circuitry below the level of SCI. All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included. The inclusion of AIS A and B ensures we can simply detect any additional volitional control below the motor level of injury. A caregiver or companion must be available to assist subjects who require assistance. We have chosen to set the age limit to 60 years as the upper limit of the study, because persons above 60 years old are likely to have cardiovascular problems that can prevent engagement in strenuous physical activity for 12 months. A written clearance by the medical doctor to ensure that the participant was safely able to engage in the program. Women on contraceptives may be included in the study.Participants may be excluded from the current trial if any of the following pre-existing medical conditions are present: (1) Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia; (2) Unhealed fracture in either lower or upper extremities; (3) Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture >20°. (4) Untreated or uncontrolled hypertension defined as high resting blood pressure >140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture; (5) Other medical conditions including cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, or symptomatic urinary tract infection; (6) Unable to fit in the device for any reason; (7) Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons; (8) Implanted pacemakers and/or implanted defibrillator devices; (9) DXA T-Score <−2.5 standard deviations of the total body. Total hip bone mineral density (BMD) T-scores <−3.5 and knee BMD scores of less than 0.6 g/cm