Proprioception Testing in Persons With Sensorimotor Impairment

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Stroke; Acquired Brain Injury; Spinal Cord Injury

Treatments: Device: AMES Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01974635

00009635

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

AMES Therapy and Diagnostic

Experimental group

Description:

During treatment, the AMES device rotates the hand, into flexion and extension, while the patient assists with this motion,and while the lengthening muscle(s) are vibrated mechanically. At the end of the treatment, several diagnostic tests are performed to measure the participant's level of proprioceptive perception. This study provides for 25 AMES treatments and diagnostic tests over 8-13 weeks, at a rate of 2-3 sessions per week.

Treatment:

Device: AMES Therapy