Proprioception Testing in Persons With Sensorimotor Impairment

Not Applicable

Terminated

• Conditions: Stroke; Spinal Cord Injury; Acquired Brain Injury
• Interventions: Device: AMES Therapy

• Registration Number: NCT01974635
• Lead Sponsor: Oregon Health and Science University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-27
• Study First Posted: 2013-11-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2019-03-29
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-11
• Last Update Submitted: 2019-06-11
• Results First Posted: 2019-06-13
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMES Therapy and Diagnostic	AMES Therapy	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.

Primary Outcome Measures

Name	Time	Method
Joint Position Test - AMES Device	Immediately after each treatment on the 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.

Secondary Outcome Measures

Name	Time	Method
Frisbee Test - Device	After each treatment on the AMES 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.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States