Status:
TERMINATED
Spinal Cord Injury Leg Rehabilitation
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Shepherd Center, Atlanta GA
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injury
Paraplegia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 leg...
Detailed 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. Furth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01498991
Start Date
November 1 2011
End Date
November 1 2016
Last Update
May 24 2019
Active Locations (2)
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1
Shepherd Center, Crawford Research Center
Atlanta, Georgia, United States, 30309
2
Oregon Health and Science University
Portland, Oregon, United States, 97239