Paraplegic mobility remains an accessibility problem for many individuals despite great advances in longevity and passage of the Americans with Disabilities Act.To be able to visit the home of a friend without having to be carried in, to stand in a meeting and present one's views, to participate fully in walking ceremonies are currently unrealistic goals. Lack of weight-bearing makes bones weak and easily broken and lack of use of joints allows them to become contracted and unable to move. Atrophic muscles fail to provide protection to the skin and bones and pressure sores are common. Preliminary work has resulted in braces which can allow standing and walking but they are inconvenient, labor-intensive and slow. Stair climbing is generally impossible. Functional neural stimulation (FNS) has given the capability of walking up to over one meter per second, of climbing stairs with one rail and one crutch, of side and back stepping, and for standing up to an hour. This requires 48 channels of percutaneous stimulation and energy similar to brisk jogging. The major problems are achieving stability through excessive muscle activation and the percutaneous interfaces. An 8 channel fully implanted radio frequency controlled and powered stimulation system has been successful for hand control for over 7 years and for standing and transfers for 1.5 years.A simple outpatient percutaneous technique allows initial percutaneous stimulation of any muscles and then transformation into an implanted system. This proposal combines the 8-channel implanted stimulator with a trunk hip knee ankle foot orthosis with programmable joint locks to provide more immediate probability to paraplegic subjects and to allow study of a functional system with 8 channels instead of 48. The proposal couples the FNS, mechanics, control systems, and spinal surgical expertise of CWRU with the orthotics expertise of NYU and Stanford. The major contribution to previous work is that the implantable stimulation allows independent access to all muscles necessary for function such as stair climbing, including the hip flexors. Additionally, the concept of programmable braking of brace points has not previously been used this extensively. The specific objectives are to first design a controlled joint lock prototype and place it in a prototype orthosis. Implantation of six subjects will also begin immediately, but current percutaneous subjects will be used initially. The subjects will then be programmed and trained in functional use of the system. Evaluation will include assessment of function, reliability, safety, ease of use, energy used, appearance and cost.
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