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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT02592668
Eligibility Criteria:
Inclusion Criteria:
* Stable medical condition without \*cardiopulmonary disease or \*dysautonomia that would contraindicate standing or stepping with body weight support training
* No current anti-spasticity medication regimen
* Non-progressive spinal cord injury between the vertebral levels of C7 \& T10
* American Spinal Injury Association grading scale of A or B
* Sensory evoked potentials are either not present or have a bilateral delay
* Segmental reflexes remain functional below the lesion
* At least 2-years post-injury.
Exclusion Criteria:
* Pregnancy at time of enrollment
* Failure to obtain consent
* Prisoners
* Children (age less than 21)
* Any patient identified as unsuitable for this protocol by the Mayo study team
* Skeletal fracture
* Osteoporosis with Dual-energy X-ray absorptiometry (DEXA) t score ≤-3.5
* Uncontrolled urinary tract infections
* Presence or history of frequent decubitus ulcers
* Clinical depression
* Drug abuse
* Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training
* Current anti-spasticity medication regimen
* Voluntary motor response present in leg muscles
* Volitional control during voluntary movement attempts in leg muscles as measured by electromyography (EMG) activity
* Brain influence on spinal reflexes as measured by EMG activity
* Recordable motor evoked potential in the lower limbs with transcranial magnetic stimulation
* Implanted cardiac pacemaker
* Implanted defibrillator
* Other implanted metallic or active body worn medical electronic device such as an insulin pump
* \*Cardiopulmonary disease that would result in exclusion from the study will be defined as clinically diagnosed chronic obstructive pulmonary disease, cardiac failure, and heart arrhythmia that would contraindicate sudden changes in body position such as sit-to-stand and stepping
* \*Excessive and uncontrolled autonomic dysreflexia characterized by symptomatic hypotension, light headedness and hypertension, flushing and bradycardia. Additionally blood pressure monitoring will be available at all times during rehabilitation and assessment times.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02592668
Study Brief:
Protocol Section:
NCT02592668