Kessler Foundation has been named awardee of a three-year grant for $1.8 million from the Department of Defense Spinal Cord Injury Research Program. Gail Forrest, PT, PhD, is principal investigator for the randomized, double-blinded, controlled, multi-site clinical trial, which will test strategies to improve bone and muscle strength after spinal cord injury. Dr. Forrest is assistant director of Human Performance & Engineering Research at Kessler Foundation. Two additional sites will participate - the University of Louisville-Frazier Rehab and the James J. Peters VA Medical Center, Bronx, New York. The study is slated to begin in the fall of 2014.
"We are pleased to share our decades of experience in spinal cord injury research to address the critical need for interventions to improve health and quality of life for individuals with SCI," said Rodger DeRose, president and CEO of Kessler Foundation. "Together with our collaborators, we have confidence that safe and effective solutions will be developed that minimize secondary complications of spinal cord injury."
Within the first six months of spinal cord injury, rapid wasting of the muscle and bone occurs in the lower limbs, often resulting in osteoporosis. Many men also experience significant declines in serum testosterone levels. "These lead to further complications," noted Dr. Forrest, "including elevated risks for fractures, weight gain, cardiovascular disease, urinary tract infection, and pressure ulcers - all of which adversely affect quality of life, and raise the costs of care. This is why developing interventions to address bone and muscle loss is so important."
Kessler Foundation proposes a three-armed intervention strategy for treating muscle and bone called the "Activity-Dependent Rehabilitation Model" - combination therapy with stand training, testosterone replacement therapy, and electrical stimulation. This strategy is likely to yield interventions readily transferable to clinical care," said Dr. Forrest.
Across the three sites, 56 men with subacute to chronic SCI and low testosterone levels will be enrolled and randomized into one of 4 groups: 1) Stand Training only; 2) Stand+Electrical Stimulation; 3) Stand Training+ Testosterone; 4) Stand Training+Testosterone+Electrical stimulation. Each research participant will complete 60 sessions of training.