The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Brief Title

Evaluation of an Advanced Lower Extremity Neuroprostheses

Official Title

Evaluation of Advanced Lower Extremity Neuroprostheses

Brief Summary

The purpose of this study is to evaluate a surgically implanted functional electrical <br /> stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people <br /> with various degrees of paralysis.

Detailed Description

Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of
the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following
implantation, patients undergo training in standing, transfers and other advanced mobility
skills using the functional electrical stimulation system. A prescribed course of exercise,
functional training and rehabilitation with the implanted stimulation system, followed by
laboratory assessments of strength, balance and functional abilities with and without the
system, as well as the technical performance of the implanted components. Home-based training
follows prior to discharge for home use of the system.

Patients are followed at 6 and 12 months after discharge and then annually thereafter.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Inclusion Criteria:

  -  Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition

  -  Skeletal maturity

  -  Ability to understand and sign informed consents

  -  Disability equivalent to ASIA impairment scale A (complete motor and sensory
     deficits), B (sensory sparing) or C (motor and sensory sparing)

  -  Intact and electrically excitable lower motor neurons

  -  Greater than 6 months since injury or onset

  -  Range of motion within normal limits

Exclusion Criteria:

  -  Pacemaker

  -  Cardiac arrythmia

  -  Pregnancy

  -  Contractures of any major joint of upper or lower extremities

  -  Uncontrolled seizure disorder

  -  Obesity

  -  Untreated substance abuse

  -  Immunodeficiency

  -  Frequent urinary tract infections

  -  Presence of decubitis ulcers

  -  Acute or chronic psychological problems

  -  Acute orthopaedic problems

  -  Pulmonary compromise

  -  Renal compromise

  -  Circulatory compromise

  -  History of spontaneous fractures or insulin dependent diabetes