Rise 2-Italy trial: how to enroll and start stimulation. A case report.

The Rise Project opens innovative perspectives about a comprehensive rehabilitation approach to “chronic and complete” SCI (spinal cord injury) patients. Health maintenance, social participation and personal body image values may change during time and aging of these people. Denervated muscles of the spine and lower limbs change their biological properties. Loss of sensibility and muscles changes are well-known causes of pressure ulcers. Loss of muscle cells is important for negative effect of gravity on neuropathic pain, cardiac workload, venous blood pressure, respiratory reserve, personal and social body image. Actually electrical stimulation devices of Italian rehabilitation centers are not useful to stimulate a complete denervated muscle (warm and hot effect and neuropathic sensation are common effects of those devices on incomplete SCI patients). Social contest and personal values of patients and rehabilitators (including biomedical experts, engineering experts and bioscience experts) can help to start this integrative project. A personal experience is here described. A young male patient, 30 years old was recovered 9 months ago in a Intensive Care Unit for a car-crash injury. Reported injuries were: a mild brain traumatic injury scored 14 by GCS (a closed-head injury), multiple bone fractures: thoracic and lumbar bone fractures, rib fractures, right pneumothorax. Patient was sedated and a tracheal intubation was performed (artificial ventilation was performed for 7 days, anesthesiologic sedation lasted 6 days). First neurologic examination diagnosed a severe spinal cord injury (spinal cord traumatic injury) and a spinal stabilization surgery was performed after 10 days. After 6 months of ICU (intensive care unit) the patient was treated in a rehabilitation unit and evaluated by the rehabilitative team. A L1-complete-SCI (no motor or sensory sensation below L1 level, no anal sensation) without pressure ulcers was diagnosed and a rehabilitative project was to ameliorate functional independence and social participation. Patient learned to use a manual wheelchair, to upper and lower body dressing ability, to self-perform intermittent catheterization for a severe urinary retention (urologic diagnosis was a complete denervated vescical muscle), to use devices for fecal elimination. Sexual complete impotence and endocrinologic syndrome was also diagnosed. The family of the patients was involved in this learning process. After dismission from the rehabilitation unit, 4 months later, the patient was teached to use thecnologic devices for independent car driving. Clinical integrative evaluation performed by a translational myologist and physiatrist considered a potential clinical amelioration of reduced gluteal and quadricepts muscles to prevent pressure ulcers and ameliorate respiratory and global resistance to “nomal” daily activities workload. Electrical stimulation test performed by a myologist and a global water aerobics exercise program was performed. The RISE Project was explained to the patients and to his family. The technical machine used for the electrical stimulation (a FES device) is not a commercial device used in rehabilitation centers. The first myology evaluation test diagnosed a selective excitabily muscles pattern and a non-muscle-tissue fibrotic syndrome was diagnosed. The myologist and physiatrist decide to ask the patient about a participation to the RISE Project. A physiotherapist planned a treatment for the fibrotic syndrome (hyperflexion of ischiocrural tendons) by using water exercises and stretching programs. A quantitative analysis of muscle dimension was planned. The patient gave the consent to be evaluated in Vienna by dr. Helmut Kern for enrolment in the RISE Project, that include a pre-training and a posttraining muscle biopsy. After instruction for the use of the electrical stimulator for denervated muscles, the Informed Consent Form was signed September 12, 2008. Then, both final evaluation for enrolment and pre-FES muscle biopsies were performed in Vienna [1]. The program with the special electrical device for home-based training (not available in Italy) is integrated in a rehabilitative plan and is used to ameliorate denervated muscles properties and to prevent ulcer pressure. Quantitative imaging of thigh muscles will be performed during and at the end of the two-year FES training by Ultra Sound (US), MRI, and/or TC scan.