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| Name | Class |
|---|---|
| Worcester Polytechnic Institute | OTHER |
| Massachusetts General Hospital | OTHER |
| University of Colorado, Denver | OTHER |
| University of Minnesota |
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This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on the musculoskeletal system and health-related quality of life.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate gait training | Experimental | Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study. |
|
| Delayed gait training | Other | Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton assisted gait training | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tibial stiffness | assessed by finite element analysis of quantitative cat scan (QCT) of the knee | baseline, six months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone Volume | quantitative cat scan of the knee | baseline, six months, and 12 months |
| Change in mood | Patient Health Questionnaire-9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone formation | assessed by circulating osteocalcin level | baseline, six months, and 12 months |
| Change in marrow adiposity | Assessed by quantitative cat scan of the knee |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie R Morse, DO | Craig Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34717922 | Derived | Kowalski JL, Nguyen N, Battaglino RA, Falci SP, Charlifue S, Morse LR. miR-338-5p Levels and Cigarette Smoking are Associated With Neuropathic Pain Severity in Individuals With Spinal Cord Injury: Preliminary Findings From a Genome-Wide microRNA Expression Profiling Screen. Arch Phys Med Rehabil. 2022 Apr;103(4):738-746. doi: 10.1016/j.apmr.2021.09.005. Epub 2021 Oct 27. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2026 | Jun 16, 2026 | 10 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| OTHER |
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|
| baseline, six months, and 12 months |
| Change in pain | International Spinal Cord Injury Basic Pain Data Set | baseline, six months, and 12 months |
| Change in cortical activity | assessed by brain magnetic resonance imaging (MRI) | baseline, six months, and 12 months |
| Change in health-related quality of life | psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF) | baseline, six months, and 12 months |
| baseline, six months, and 12 months |
| change in bone resorption | assessed by circulating c-telopeptide level | baseline, six months, and 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |