Spinal Cord Injury Leg Rehabilitation

Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several
thousand new injuries each year. Most recovery, following SCI, occurs in the six months
following surgery. Further recovery after 12 months is unusual.

In this study 10 subjects, more than 1 year post injury, will be enrolled to test the safety
and efficacy of a new type of robotic therapy device known as the AMES device. The aim of
this Phase I/II study is to investigate the use of assisted movement and enhanced sensation
(AMES) technology in the rehabilitation of the legs of participants with incomplete SCI.

Inclusion Criteria:

- Paraplegia or tetraplegia due to SCI

- At least 1 year post incomplete Spinal Cord Injury

- Can tolerate sitting upright for at least one hour

- Capable of weight-bearing and taking a step with or without an assistive device

- On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5
level

- Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee
extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for
each of these muscles in the qualifying leg

Exclusion Criteria:

- Fracture of the treated limb resulting in loss of range of motion

- Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma
with no evidence of structural abnormalities on brain images will qualify for the
study), or other neurological injury or disease

- DVT of the treated extremity

- Peripheral nerve injury of the treated extremity

- Osteo- or rheumatoid-arthritis limiting range of motion

- Contractures equal to or greater than 50% of the normal ROM

- Skin condition not tolerant of device or sitting upright

- Progressive neurodegenerative disorder

- Botox treatment of the treated extremity in the prior 5 month

- Chronic ITB therapy

- Uncontrolled seizure disorder

- Uncontrolled high blood pressure/angina

- Pain in affected limb or exercise intolerance

- Participation in another therapy or activity-based program

- Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and
ankle plantarflexors outside the range of 3-9