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:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01244594
Eligibility Criteria:
Inclusion Criteria:
* Cervical or thoracic SCI of greater than 6 months duration
* American Spinal Injury Association Impairment Scale (AIS) levels A (motor and sensory complete) or B (motor complete)
* Intact lower motor neurons to the quadriceps, hamstrings, and gluteal muscles
Exclusion Criteria:
* History of renal or bladder stones or renal impairment
* Presence of conditions that require chronic steroids
* Symptomatic or known cardiac disease
* Pulmonary disease limiting exercise tolerance
* Ventilator dependency
* Implanted devices that may be adversely affected by the FES system
* Lower extremity fragility fractures in the previous 3 months
* Severe spasticity in legs
* Presence of a Grade 2 or higher pressure ulcer
* Severely limited range of joint motion
* Heterotopic ossification of joints in the lower extremities
* Uncontrolled autonomic dysreflexia
* Dislocation of one or both hips
* Pregnancy or plans to become pregnant during the study
* Post menopausal, if female
* Current seizure disorder
* Participation in activities involving electrical stimulation or activity based therapy within the past 3 months
* Participation in a neuroregenerative intervention within the past 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01244594
Study Brief:
Protocol Section:
NCT01244594