Status:
COMPLETED
Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Shepherd Center, Atlanta GA
Conditions:
Spinal Cord Injury
Tetraplegia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 an...
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
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00833105
Start Date
January 1 2009
End Date
January 1 2012
Last Update
May 1 2019
Active Locations (2)
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1
Shepherd Center
Atlanta, Georgia, United States, 30309
2
Oregon Health and Science University
Portland, Oregon, United States, 97006