Where arm functioning has been compromised due to a stroke, brain injury, or other neurological injury and rehabilitative progress is to be obtained in the upper extremity, it is crucial to limit over-stretching of the shoulder joint (attributed to lost muscle tone) and to control pain. Medeon, LLC is actively working with rehabilitation experts to develop the Shoulder Subluxation Optimal Support (Shoulder SOS) in support of these objectives and to advance the field of rehabilitation. The Shoulder SOS purposefully combines an innovative new anchoring belt design, a unique adjustable over-the-shoulder support, and distal limb control to address long-standing deficiencies identified in existing sling and support products. The resulting device is simple, intuitive to don, and gives therapists considerable versatility in how they stabilize and position each patient's arm and shoulder capsule during sitting, standing, and in ambulation. Phase I of this three-phase Small Business Innovation Research (SBIR) program is directed at using recognized metrics to demonstrate the Shoulder SOS adequately controls the shoulder complex to limit glenohumeral subluxation (GHS) and reduce patients'pain levels. Moreover, testing will also help determine whether the device improves comfort and ease of donning to facilitate increased compliance with prescribed usage schedules. Formal clinical validation testing of the Shoulder SOS will be carried out at Spalding Rehabilitation Hospital's facility and will involve twenty (20) subjects, each of whom will be evaluated over a six (6) week period. Phase II will encompass implementing design refinements that always come to light in Phase I, expanding the basic support concept to address more complex upper limb needs and to increase its clinical versatility still further so therapists can maximally benefit their patients, and establishing manufacturing infrastructure to fabricate commercial medical-quality product. In Phase III, commercial product will be introduced into the marketplace for prescription. This research effort intentionally leverages a significant but overlooked opportunity to benefit hundreds of thousands of men and women in the United States who daily contend with the aftermath of stroke or other neurological disorders and who need innovative new therapeutic tools. Medeon submits this is an important and worthwhile endeavor in keeping with the spirit and purposes of the National Institute of Neurological Disorders and Stroke (NINDS) SBIR program.

Public Health Relevance

Existing commercial shoulder slings and support devices for the upper limbs do not provide key functional characteristics needed to optimally rehabilitate stroke and neurological injury patients. An innovative new support system has been developed to give therapists versatility they need to control pain and shoulder malalignment associated with compromised upper-limb muscle tone. Simple, intuitive donning and improved comfort will help more patients achieve greater rehabilitation success and enjoy a higher quality of life.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-MOSS-F (15))
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Ansel, Beth
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Medeon, LLC
United States
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