Acquired Brain Injury, Spinal Cord Injury, Stroke
Conditions
Keywords
Spinal Cord Injury, Robotic therapy, Rehabilitation, Sensation, Movement, Proprioception, Stroke, Acquired Brain Injury
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.
Interventions
DEVICEAMES 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.
Sponsors
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMES Therapy 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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | AMES Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 29.5 years STANDARD_DEVIATION 3.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
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.
Time frame: Immediately after each treatment on the AMES Device
Population: Device used for eye-blinks did not perform as expected. Study terminated prior to any further analyses.
Secondary
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.
Time frame: After each treatment on the AMES device.
Population: Eye-blink response device didn't perform as expected. Study terminated before any analysis performed.