Spinal Cord Injury Leg Rehabilitation
Stopped early · Phase 1/Phase 2
Conditions studied: Spinal Cord Injury, Paraplegia, Quadriplegia, Tetraplegia
In brief
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.
Key facts
- Study ID
- NCT01498991
- Run by
- Oregon Health and Science University
- People needed
- 2
- Starts
- 2011-11-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2019-05-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Shepherd Center, Crawford Research Center — Atlanta, Georgia, United States
- Oregon Health and Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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