NCT02533713
Unknown
Not Applicable
Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life: A Randomized Clinical Trial
ConditionsOsteoporosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- Craig Hospital
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in tibial stiffness
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on the musculoskeletal system and health-related quality of life.
Detailed Description
Investigators will test if exoskeleton-assisted ambulation confers skeletal benefits in a dose-dependent fashion. Investigators also will test if reintroduction of ambulation will be associated with improvements in quality of life due to improvements in mood, pain, and functional connectivity of emotional networks in the brain.
Investigators
Leslie Morse
Medical Director of Research
Craig Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Change in tibial stiffness
Time Frame: baseline, six months, and 12 months
assessed by finite element analysis of quantitative cat scan (QCT) of the knee
Secondary Outcomes
- Change in pain(baseline, six months, and 12 months)
- Change in bone Volume(baseline, six months, and 12 months)
- Change in mood(baseline, six months, and 12 months)
- Change in cortical activity(baseline, six months, and 12 months)
- Change in health-related quality of life(baseline, six months, and 12 months)
Study Sites (1)
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