Proprioception Testing in Persons With Sensorimotor Impairment

Stroke Clinical Trial

Official title:

Proprioception Testing in Persons With Sensorimotor Impairment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01974635
• Other study ID #: 00009635
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke
• Wounds and Injuries

Intervention

Device:
• AMES Therapy
During the therapy session, the AMES device rotates the hand into flexion and extension, while the patient assists with this motion, as possible. At the same time, the AMES device provides sensory stimulation by vibrating the tendons of muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so that the sensory stimulation remains functionally related to the movement. The subject will receive visual bio-feedback of their contribution to the motor movement.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. Erratum in: J Neurol Phys Ther. 2014 Apr;38(2):147. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint Position Test - AMES Device	Testing proprioceptive sensation, the subject, with eyes closed, attempts to identify verbally the direction of motion (i.e., flexion or extension) as the AMES device randomly moves the subject's thumb and fingers, or the whole hand, into flexion and extension.	Immediately after each treatment on the AMES Device
Secondary	Frisbee Test - Device	Testing proprioceptive sensation, the AMES device moves the subject's wrist through a 30 degree range, at variable speeds, as the subject attempts to identify when their wrist reaches a particular target, either by opening contact between the thumb and index finger (if possible) or blinking the eyes. The subject receives feedback about the accuracy of the testing.	After each treatment on the AMES device.