Condition: Amputation · Sponsor: Brigham and Women's Hospital
The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are: 1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA) 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham \& Women's Hospital/Brigham \& Women's Faulkner Hospital (BWH/BWFH), Walter Reed National M…
This description comes directly from the study's public registry record.
Matthew J Carty, MD · 6179834555 · mcarty@partners.org
Always discuss trial participation with your own doctor first.
| Walter Reed National Military Medical Center | Bethesda, Maryland, United States | Recruiting |
| Brigham & Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Massachusetts Institute of Technology Media Lab | Cambridge, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT03882073