|3 Mar '15||
Trial name was updated.
Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury
The Summary of Purpose was updated.
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).
The purpose of this study is to investigate how the nervous system interprets joint position and movement. This will contribute to a broader knowledge of understanding how the human central nervous system (CNS), which includes the brain and spinal cord, coordinates voluntary movement.
The description was updated.
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.
In motor nervous system disorders, such as stroke, the CNS is unable to coordinate normal voluntary movement. This is often caused by malfunctioning proprioception. Proprioception is one's sense of the relative position of neighboring body parts. It allows an individual to feel the orientation of one body part to another. It also provides information about the rate and direction of movement so that an individual can change muscle contraction immediately as incoming information about external forces is received. The two main components of proprioception include sensory nerve cells located in the inner ear and stretch receptors located in muscles, skin, tendons, and joint-supporting ligaments. The purpose of this study is to determine how proprioception is communicated from the stretch receptors in skin, joints, and muscles to the CNS. Specifically, the study will compare the differing roles of agonists, muscles that cause movement, versus antagonists, muscles that oppose agonists, in proprioception. Participants will be assigned to one of seven substudy groups. Each group will partake in one or more study experiments, which will each take 1 to 4 hours. Participants enrolled in more than one experiment will report to the study site on separate days. For each experiment, the participant will sit at a table with a specialized device, called a manipulandum, which has motorized elbow, wrist, and finger manipulators to control the movement and position of a participant's arm. Depending on the experiment, several forms of joint rotation and arm movement will be carried out by either the participant or the manipulandum. Electrical activity of certain muscles and nerves will be recorded in all experiments by various kinds of electrodes. A tendon vibrator will be used in some experiments to activate muscle receptors that signal to what extent and how fast a muscle is contracting or stretching. Regional anesthesia will also be used in some experiments to reduce sensory input from the skin and joints. Participants will receive follow-up phone calls after an experiment to check for any side effects from procedures.
Trial was updated to "Phase 1/Phase 2."
The eligibility criteria were updated.
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
Exclusion Criteria for Anesthesia: - Known neuromuscular abnormalities - Known allergies or hypersensitivity to anesthetics - Blood clotting or bleeding disorder - Use of anticoagulants - Psychologically inappropriate behavior (e.g., apprehension, uncertainty with procedure) - Significant history of any cardiovascular problem Exclusion Criteria for Nerve Recording by Electrode: - Significant history of fainting or problems with blood pressure control
|1 Mar '13||
A location was updated in Portland.
The overall status was removed for Oregon Health and Science University.