Seated Balance Using the Indego™

Exclusion Criteria

• •1. Diagnosis of neurological injury other than SCI;
• •2. Progressive condition that would be expected to result in changing neurological status;
• •3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
• •4. Anthropocentric incompatibility to be fitted with the device;
• •5. Traumatic or high impact lower extremity fracture within the past 2 years;
• •6. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
• •7. Knee BMD \< 0.60 gm/cm2;
• •8. Total hip BMD T-scores \< -3.5;
• •9. Untreatable severe spasticity judged to be contraindicated by the Site Physician;
• •10. Flexion contracture that is incompatible with the device;
• •11. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \> 00);
• •12. Fracture of the foot by x-ray and confirmed by CT;
• •13. Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg);
• •14. Unresolved orthostatic hypotension (systolic blood pressure \<90 mmHg; diastolic blood pressure \<60 mmHg) as judged to be contraindicated by the Site Physician;
• •15. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
• •16. History of seizure;
• •17. Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
• •18. History of stroke, brain tumor, brain abscess, or multiple sclerosis;
• •19. History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
• •20. History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
• •21. Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
• •22. Pregnancy or women who plan to become pregnant during the study period.