Proprioception Testing in Persons With Sensorimotor Impairment
Primary Purpose
Spinal Cord Injury, Stroke, Acquired Brain Injury
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMES Therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Robotic therapy, Rehabilitation, Sensation, Movement, Proprioception, Stroke, Acquired Brain Injury
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.
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMES Therapy and Diagnostic
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01974635
First Posted
October 21, 2013
Last Updated
June 11, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01974635
Brief Title
Proprioception Testing in Persons With Sensorimotor Impairment
Official Title
Proprioception Testing in Persons With Sensorimotor Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Device used for eye-blinks did not work as performed.
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Stroke, Acquired Brain Injury
Keywords
Spinal Cord Injury, Robotic therapy, Rehabilitation, Sensation, Movement, Proprioception, Stroke, Acquired Brain Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMES Therapy and Diagnostic
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
AMES Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Joint Position Test - AMES Device
Description
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.
Time Frame
Immediately after each treatment on the AMES Device
Secondary Outcome Measure Information:
Title
Frisbee Test - Device
Description
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.
Time Frame
After each treatment on the AMES device.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Cordo, Ph.D
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Director
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18645190
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.
Results Reference
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PubMed Identifier
24685386
Citation
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.
Results Reference
background
PubMed Identifier
24232364
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.
Results Reference
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Proprioception Testing in Persons With Sensorimotor Impairment
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