NIH Clinical Trial Conducted by Jefferson/Magee Spinal Cord Injury Center

Compares Spinal Cord Therapies

 

A first-ever randomized study, undertaken to determine the best therapy for treating a paralyzing spinal cord injury, is currently underway at the Regional Spinal Cord Injury Center at Thomas Jefferson University Hospital and Magee Rehabilitation Hospital.

Funded by the National Institute of Child Health and Human Development of the National Institutes of Health, the study is in the fifth and final year.

"Until now, there have been no scientific studies in spinal cord injury to define which mode of therapy works best," explained principal investigator John Ditunno, Jr., M.D., professor of Rehabilitation Medicine, Jefferson Medical College of Thomas Jefferson University, and director of the Regional Spinal Cord Injury Center.

Patients who have sustained an acute incomplete spinal cord injury will be eligible for the study. Approximately half of those who are treated at the Regional Spinal Cord Injury Center suffer this type of injury. During the study, participants will be treated with either conventional therapy which utilizes daily mobility retraining or a combination of conventional interventions and body weight-supported ambulation therapy.

Actor Christopher Reeve, who sustained a spinal cord injury after an equestrian accident in 1995 and is now a quadriplegic, is currently working with the weight-supported ambulation therapy at the University of California at Los Angeles.

"The primary goal is to determine which type of therapy produces better ambulation status or walking ability," said Michael Saulino, M.D., Ph.D., instructor in Rehabilitation Medicine and assistant director of Resident Education in the Department of Rehabilitation Medicine, Jefferson Medical College of Thomas Jefferson University. "We also want to learn whether or not motor skills are improved." Dr. Saulino is also a principal investigator and physician at Magee Rehabilitation Hospital.

The theoretical basis of body weight-supported therapy is a concept known as a central pattern generator.

"This is based on a belief that the human spinal cord has an intelligence all its own that can generate steplike electrical patterns when exposed to sensations like walking," Dr. Ditunno said.

Patients must have sustained their spinal cord injury within eight weeks of taking part in the study, and have some feeling or movement below the level of their injury. Subjects undergoing the weight-supported ambulation, which take place at Magee, are placed in a parachute harness and positioned over a treadmill. Once the treadmill belt is moving, the investigation team, which includes physical therapists, assist moving patient's legs in a way that optimize sensory inputs. Clinical research has shown that patients with certain types of spinal cord injuries who undergo this type of therapy have enhanced locomotor activity.

In the first year of the study, set up, staff training, and the initial enrollment of patients occured. During years two, three and four, patient enrollment continued and patients received specified therapies.

The fifth year is follow-up and data analysis.

The Regional Spinal Cord Injury Center is one of five centers nationwide participating in the study. The other participating centers are Rancho Los Amigos in Los Angeles, Ohio State University in Columbus; Shepherd Rehabilitation Center in Atlanta and a combined Canadian site involving McGill University in Montreal and the University of Ottawa.

Thomas Jefferson University Hospital, in affiliation with the Magee Rehabilitation Hospital, is designated as one of the nation's 16 regional Research Spinal Cord Injury Centers, and the only one in the Delaware Valley. The Regional Spinal Cord Injury Center is federally designated as a Model System Spinal Cord Injury Center. These designations are by the National Institute on Disability and Rehabilitation Research (NIDRR) of the U.S. Department of Education.

Jefferson and Magee, along with MossRehab, all members of the Jefferson Health System, were recently named by U.S.News & World Report in the magazine’s "America's Best Hospitals" issue as among the top medical rehabilitation facilities in the nation, and the only Philadelphia-based providers named in the magazine's rehabilitation category.

The Regional Spinal Cord Injury Center, which has treated more than 2,500 individuals with spinal cord injury, provides a coordinated multidisciplinary system of acute care and rehabilitation for persons with spinal cord injury. It offers a variety of services from the moment of injury, through acute care and rehabilitation phases, into follow-up care and community reintegration. With over 70 percent of persons with spinal cord injury admitted within three days of injury, the Spinal Cord Injury Center has demonstrated a mortality rate of five percent (as compared to a 17 percent national average) and has significantly reduced the severe secondary complications of traumatic spinal cord injury.

Magee Rehabilitation Hospital, a founding member of the Jefferson Health System, opened in 1958 as the Philadelphia region's original provider of physical and cognitive rehabilitation. The not-for-profit health organization provides lifetime rehabilitation and wellness programs for persons with amputations, orthopedic injury, joint replacement, arthritis, pulmonary disorders, multiple sclerosis, Parkinson's disease, cancer, geriatric rehabilitation needs, neurologic disorders, pain syndromes, work-related injury and cardiac disease.

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