Proprioception Testing in Persons With Sensorimotor Impairment

NCT01974635 | Terminated Results DMC

• 1 other identifier: 00009635
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Stroke; Acquired Brain Injury

Keywords

Spinal Cord Injury; Robotic therapy; Rehabilitation; Sensation; Movement; Proprioception; Stroke; Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frisbee Test - Device

  After each treatment on the AMES device.

Study Arms (1)

AMES Therapy and Diagnostic

EXPERIMENTAL

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.

Device: AMES Therapy

Interventions

AMES Therapy 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.

AMES Therapy and Diagnostic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

• 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.

  PMID: 18645190 BACKGROUND

• 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.

  PMID: 24685386 BACKGROUND

• 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.

  PMID: 24232364 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma

Results Point of Contact

• Title: Paul Cordo
• Organization: AMES Technology Inc.

pcordo@amesdevices.com

15039706129

Study Officials

• Paul J Cordo, Ph.D

  Oregon Health and Science University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Sub-Investigator

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 1, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 13, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-06

Locations

US (1)