Proprioception Testing in Persons With Sensorimotor Impairment

NCT ID: NCT01974635

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Spinal Cord Injury; Stroke; Acquired Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

AMES Therapy and Diagnostic

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.

Group Type: EXPERIMENTAL

AMES Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Cordo

Site Sub-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J Cordo, Ph.D

Role: STUDY_DIRECTOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18645190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24685386 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24232364 (View on PubMed)

Other Identifiers

00009635

Identifier Type: -

Identifier Source: org_study_id