Seated Balance Using the Indego™ (NCT04047992)
"The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™"
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (23 items).
Location: James J. Peters VA Medical Center — The Bronx, New York
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Diagnosis of neurological injury other than SCI;
- Progressive condition that would be expected to result in changing neurological status;
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
- Anthropocentric incompatibility to be fitted with the device;
- Traumatic or high impact lower extremity fracture within the past 2 years;
- Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
- Knee BMD \< 0.60 gm/cm2;
- Total hip BMD T-scores \< -3.5;
- Untreatable severe spasticity judged to be contraindicated by the Site Physician;
- Flexion contracture that is incompatible with the device;
- Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \> 00);
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- James J. Peters VA Medical Center — The Bronx, New York
📞 Contact the Study Coordinator
Phone: (718) 584-9000
Email: Steven.Knezevic@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: The participants will receive 36 sessions of EAW training in 12 weeks.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.