Clinical trial NCT01974635: Proprioception Testing in Persons With Sensorimotor Impairment
Official title: Proprioception Testing in Persons With Sensorimotor Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Stroke
Acquired Brain Injury
Keywords: Spinal Cord Injury
Robotic therapy
Rehabilitation
Sensation
Movement
Proprioception
Stroke
Acquired Brain Injury
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, an FDA-cleared device and type of treatment called "AMES," which stands for Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or stroke improves along with movement through treatment. We hypothesize that measureable improvement in the sensation of the upper limb will precede improvement in functional movement.

Detailed description: The AMES device performs tests of sensorimotor impairment as well as delivering therapy. In this study, we are testing 2 additional diagnostic tests (i.e., Joint Position Test and "Frisbee" Test), both of proprioception, in order to determine which of the two is the best test of proprioception. Our hypotheses are: (1) both sensation and movement recover with AMES treatment, (2) sensory recovery precedes that of movement, (3) robotic delivery of the Joint Position Test produces more reliable test results than does manual delivery of this test, and (4) the Frisbee Test results will parallel those of the Joint Position Test.

Eligibility criteria: Inclusion Criteria:

* Traumatic incomplete SCI, stroke or acquired brain injured ABI subjects.
* Able to tolerate sitting upright at for at least 1 hour.
* Significant, but not complete, motor deficit in the hand and wrist, as determined by the Study Physician performing the screening.
* Significant, but not complete somatosensory deficit in the hand and wrist as determined by the Study Physician performing the screening.
* Cognitively and behaviorally capable of complying with the regimen.

Exclusion Criteria:

* Fracture of the treated limb resulting in loss of range of motion.
* Progressive neurodegenerative disorder.
* DVT of the treated extremity.
* Uncontrolled seizure disorder.
* Uncontrolled high blood pressure/angina.
* Osteo- or rheumatoid arthritis limiting range of motion
* Contractures equal to or greater than 50% of the normal ROM.
* Chronic ITB therapy.
* Peripheral nerve injury of the treated extremity.
* Pain in affected limb or exercise intolerance.
* Participation in another therapy or activity-based program.
* Skin condition not tolerant of device.

Primary outcomes:
measure: Joint Position Test - AMES Device
timeFrame: Immediately after each treatment on the AMES Device
Secondary outcomes:
measure: Frisbee Test - Device
timeFrame: After each treatment on the AMES device.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Paul J Cordo, Ph.D
role: STUDY_DIRECTOR
References:
citation: Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.
citation: Backus D, Cordo P, Gillott A, Kandilakis C, Mori M, Raslan AM. Assisted movement with proprioceptive stimulation reduces impairment and restores function in incomplete spinal cord injury. Arch Phys Med Rehabil. 2014 Aug;95(8):1447-53. doi: 10.1016/j.apmr.2014.03.011. Epub 2014 Mar 28.
citation: Cordo P, Wolf S, Lou JS, Bogey R, Stevenson M, Hayes J, Roth E. Treatment of severe hand impairment following stroke by combining assisted movement, muscle vibration, and biofeedback. J Neurol Phys Ther. 2013 Dec;37(4):194-203. doi: 10.1097/NPT.0000000000000023.