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

Running, not enrolling · Not applicable

Conditions studied: Osteoporosis

In brief

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

Key facts

Study ID

NCT02533713

Run by

Craig Hospital

People needed

36

Starts

2017-07-01

Expected to finish

2022-12-01

Last updated by the study team

2021-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Craig Hospital — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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