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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT01740128
Eligibility Criteria:
Inclusion Criteria:
* Males or females age 21-65 years;
* SCI duration \> 12 months;
* SCI level C2-T12;
* All SCI severity eligible for baseline testing;
* For exercise protocol, must have severity of Grade C or D on American Spinal Injury Association (ASIA) Impairment Scale, or volitional strength of at least 1/5 in two or more key lower extremity muscles, as well as at least 3/5 in both shoulder and elbow muscles;
* Able to tolerate upright position with support;
* Morphologically capable of fitting a weight-support harness and robotic treadmill system;
* Ability to give informed consent.
Exclusion Criteria:
* Unsuitable cognitive capacity as judged by the study physician;
* Diagnosis of neurological injury other than SCI, such as stroke, traumatic brain injury, or other neurological condition that the study physician considers to be exclusionary;
* Multiple spinal cord lesions;
* History of frequent autonomic dysreflexia;
* History of seizures;
* Use of medications that significantly lower seizure threshold, such as anti-psychotics, tricyclic antidepressants, amphetamines, and bupropion;
* History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;
* Deep vein thrombosis in lower extremities of less than 6 months duration;
* Pregnancy;
* (Interventional phase only): Lack of detectable tibialis anterior motor evoked potential (MEP) at baseline even with active facilitation;
* (Interventional phase only): Pressure ulcers greater than stage 1 severity on the foot, ankle, knee and/or pelvic girdle;
* (Interventional phase only): Bone mineral density of the hip (proximal femur) T-score \<3.5 standard deviations from age- and gender-matched normative data;
* (Interventional phase only): Any spasticity, contractures, or heterotopic ossification that result in inadequate range of motion of the shoulder, elbow, wrist, fingers, hip, knee, or ankle joints in the judgment of the study physician;
* (Interventional phase only): Inability to cooperate with instructions or unwilling to commit to daily training sessions for 3-4 days per week over 12-16 weeks;
* (Interventional phase only): A diagnosis of coronary artery disease that precludes moderate to intense exercise.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01740128
Study Brief:
Protocol Section:
NCT01740128