NCT04047992 Seated Balance Using the Indego™

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 20 participants in total. It began in 2018-02-01 with a primary completion date of 2025-09-30.

Brief Summary

Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.

Eligibility Criteria

Inclusion Criteria: 1. Traumatic or non-traumatic SCI ≥6 months duration of SCI; 2. Wheelchair-user for indoor and outdoor mobility; 3. Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D); 4. Able to hold the crutches in hands with or without modifications; and 5. Able to provide informed consent. 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.

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