A Phase 1/2 interventional study of AMES Treatment in Spinal Cord Injury, Paraplegia and Quadriplegia, sponsored by Oregon Health and Science University. Terminated at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by Oregon Health and Science University · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine if individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.
The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.
Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.
In this study 10 subjects, more than 1 year post injury, will be enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in the rehabilitation of the legs of participants with incomplete SCI.
1,950 studies on the registry are indexed under Spinal Cord Injuries; 507 are open to participants now.
This study's enrollment of 2 is below the median of 24 across 1,567 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.
Device: AMES Treatment
The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).
Gait Velocity
Measured by the GAITRite system
Time frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Vibration Threshold Test
Time frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Modified Ashworth Scale
Time frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Timed 10-Meter Walk Test
Time frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Gait Assessment Including Step Length and Cadence
Measured by the GAITRite system
Time frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Ankle Active Motion Test
The participants will perform an active range-of-motion (ROM) task each time they are treated with the AMES device, in which they move the affected joint to several target joint angles, guided by visual feedback on a display screen on the AMES device.
Time frame: Prior to each treatment session, on average 3 times a week
Ankle Strength
The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction .
Time frame: Prior to each treatment session, on average 3 times a week
ASIA Motor and Sensory Scores for L2-S1
Time frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
| Milestone | AMES Treatment |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Measured by the GAITRite system
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Measured by the GAITRite system
No measurements were reported for this outcome.
The participants will perform an active range-of-motion (ROM) task each time they are treated with the AMES device, in which they move the affected joint to several target joint angles, guided by visual feedback on a display screen on the AMES device.
No measurements were reported for this outcome.
The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction .
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AMES Treatment | — | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | AMES Treatment |
|---|---|
| Mean | 30 ± 1.5 |
| Sex: Female, Male(Participants) | AMES Treatment |
|---|---|
| Female | 1 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | AMES Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | AMES Treatment |
|---|---|
| United States | 2 |
Plan to share: No
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Oregon Health and Science University