Spinal Cord Injury Clinical Trial
Official title:
Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
The purpose of this research study is to evaluate an exoskeleton device and mobility skills in the device.
Currently, the treatment of muscle and bone deterioration after SCI is very limited;
therefore, there is a definite need to further understand the mechanism of breakdown in the
musculoskeletal system after a SCI, and, more importantly, find a clinical strategy that
will treat muscle and bone loss.
This pilot research grant will collect results that will be used for the design of a
multi-site randomized controlled clinical trial to determine whether a Robotic Exoskeleton
training [100 sessions; 1hr/session; 4-5 sessions/week] can improve musculoskeletal outcomes
more than other current interventions. If the overall objective is to use the progression of
technology to enhance functional ambulation for persons with a spinal cord injury, then the
investigators need to evaluate the health benefits associated with continual use of the
device.
The study will be a prospective, single-group, repeated measure design using a 2 -month lead
in to establish stability, 5-month intervention phase and 2 -month follow-up phase for
retention will be performed. Each participant will be used as his or her own control. This
project will be completed at two sites: Kessler Foundation will be the lead site that will
be under the direction of Dr. Gail F Forrest (Principal Investigator) and Spinal Cord Damage
Research Center, James J Peters VA Medical Center under the direction of Dr. Ann M. Spungen
(collaborator). Both sites have exoskeletal-assisted walking programs.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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| Completed |
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|
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|
Phase 2 | |
| Completed |
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|
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|
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| Completed |
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|
||
| Terminated |
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Phase 1/Phase 2 | |
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||
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Phase 3 | |
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