Spinal Cord Injury Leg Rehabilitation (AMES)

Oregon Health & Science University (OHSU)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Tetraplegia; Quadriplegia; Spinal Cord Injury; Paraplegia

Treatments: Device: AMES Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01498991

IRB00007762

R01NS061304-22 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine if individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.

The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

AMES Treatment

Experimental group

Description:

The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.

Treatment:

Device: AMES Treatment