Who is eligible for clinical trial NCT02533713?

Participants must meet protocol criteria for Osteoporosis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT02533713 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2021-12-06

Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life (NCT02533713)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Craig Hospital

🩺 Plain-English Summary (8th-Grade Level)

This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on the musculoskeletal system and health-related quality of life.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (10 items).

Location: Craig Hospital — Englewood, Colorado

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check 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).

3 years or more after injury,
Non-ambulatory AIS A-D spinal cord injury (C7-T12),
158-188 centimeters tall,
Weigh less than 100 kilograms,
Have a Modified Ashworth Scale (MAS) score of less than 3 in both lower extremities, and
Have sufficient upper body strength to complete sit to sit transfers.
Women of childbearing potential must agree to use contraceptive measures during participation in the study. They also will be required to have a negative pregnancy test (urine or serum) before receiving an imaging studies.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Current enrollment in another clinical trial
Pregnancy
Anyone with an initial blood pressure\>140/90 mmHg, orthostatic hypotension with symptomatic fall in blood pressure \>30 mmHg when upright,
An active grade 2 or greater pressure ulcer that can be worsened by walking in the device,
Lower extremity contractures that interfere with the ability to wear the device,
An unhealed limb or pelvic bone fracture history of other neurological disease (e.g. stroke, peripheral neuropathy, myopathy),
Active treatment for epilepsy,
Current use of medications potentially affecting bone health (bisphosphonates, androgenic steroids, estrogenic steroids, lithium, glucocorticoid use for more than 3 months).
Subjects with MRI-incompatible implants, pumps, or neurostimulators will be excluded.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Craig Hospital — Englewood, Colorado

💰 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.

🏛️ View Official NIH Record ↗