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Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury - NCT00833105-97006(Clinical Trial 267651)



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City:  Portland
State:  
OR
Zip Code: 97006
Conditions: Incomplete Spinal Cord Injury - Tetraplegia - Plegia - Paresis - Quadriplegia
Purpose: The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device. The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).
Study summary: 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 20 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 hand rehabilitation of incomplete SCI subjects.
Criteria: Inclusion Criteria: - Traumatic SCI with tetraplegia. - Male or female. - 18-65 yrs old. - At least 1 yr post-SCI. - Tolerate sitting upright at for at least one hour. - Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested. - Motor grade >1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested. - Cognitively and behaviorally capable of complying with the regimen. 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) - 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 - 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
Study is available at: Oregon Health and Science University
Portland, OR 97006
United States

Primary Contact:
Paul J. Cordo, PhD
Email: cordop@ohsu.edu
Phone: 503-970-6129
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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