Proprioception Testing in Persons With Sensorimotor Impairment

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01974635
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury; Stroke; Acquired Brain Injury	Device: AMES Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Proprioception Testing in Persons With Sensorimotor Impairment
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

• Study Director: Paul J Cordo, Ph.D, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Paul J. Cordo, Site Sub-Investigator, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01974635
• Other Study ID Numbers: 00009635
• First Posted: Nov 1, 2013
• Last Update Posted: Jun 13, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Paul J. Cordo, Site Sub-Investigator, Oregon Health and Science University: Spinal Cord Injury; Robotic therapy; Rehabilitation; Sensation; Movement; Proprioception; Stroke; Acquired Brain Injury
• Additional relevant MeSH terms: Brain Injuries; Spinal Cord Injuries; Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	AMES Therapy
Arm/Group Description	The AMES device rotates the hand into flexion and extension, while the participant assists with this motion and receives visual feedback of the motion. At the same time, the AMES device vibrates the muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so. This study provides for 25 AMES training sessions over 8-13 weeks.
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	AMES Therapy
Arm/Group Description	The AMES device rotates the hand into flexion and extension, while the participant assists with this motion and receives visual feedback of the motion. At the same time, the AMES device vibrates the muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so. This study provides for 25 AMES training sessions over 8-13 weeks. At the end of the intervention, the participant's proprioception (i.e., sense of joint position and movement) is tested by asking the participant, with eyes closed, to blink as the fingers and thumb or the wrist are rotated through a prescribed joint angle (i.e., target angle) by the AMES device.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.5 (3.5)
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 50%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Device used for eye-blinks did not perform as expected. Study terminated prior to any further analyses.

Arm/Group Title	AMES Therapy and Diagnostic
Arm/Group Description	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. AMES Diagnostic: Immediately following the therapy session, the AMES device rotates the hand into flexion and extension, while the patient, with eyes closed, indicates verbally the perceived direction of motion.
Measure Participants	0

2. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Eye-blink response device didn't perform as expected. Study terminated before any analysis performed.

Arm/Group Title	AMES Therapy and Diagnostic
Arm/Group Description	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. AMES Diagnostic: Immediately following the therapy session, the AMES device rotates the hand into flexion or extension, while the patient, with eyes closed, indicates the moment he/she perceives the hand passes through a prescribed joint angle.
Measure Participants	0

Adverse Events

Arm/Group Title	AMES Therapy and Diagnostic
Arm/Group Description	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. AMES Diagnostic: Either at baseline and 10-13 weeks later, or immediately following each therapy session, the participant performs a number of diagnostic tests to determine his/her level of proprioceptive perception.
All Cause Mortality
	AMES Therapy and Diagnostic
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AMES Therapy and Diagnostic
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Injury, poisoning and procedural complications
Fall	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	AMES Therapy and Diagnostic
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.