Craig Hospital
Englewood, Colorado, 80113, United States
NCT Number: NCT02533713
This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on the musculoskeletal system and health-related quality of life.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Englewood, Colorado, 80113, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gait training will be performed 3 times a week for about an hour for 26 weeks. Gait training will be performed by a trained clinical physical therapist. The goal is to achieve 1 hour of continuous walking on a flat surface per training session. Gait training will continue for 26 weeks (78 sessions).
Time frame: baseline, six months, and 12 months
assessed by finite element analysis of quantitative cat scan (QCT) of the knee
Time frame: baseline, six months, and 12 months
quantitative cat scan of the knee
Time frame: baseline, six months, and 12 months
Patient Health Questionnaire-9
Time frame: baseline, six months, and 12 months
International Spinal Cord Injury Basic Pain Data Set
Time frame: baseline, six months, and 12 months
assessed by brain magnetic resonance imaging (MRI)
Time frame: baseline, six months, and 12 months
psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Time frame: baseline, six months, and 12 months
assessed by circulating osteocalcin level
Time frame: baseline, six months, and 12 months
Assessed by quantitative cat scan of the knee
Time frame: baseline, six months, and 12 months
assessed by circulating c-telopeptide level
Craig Hospital
Other
Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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