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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS061304-22 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Shepherd Center, Atlanta GA | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMES Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMES Treatment | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Velocity | Measured by the GAITRite system | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Vibration Threshold Test | 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 | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Cordo, PhD | Oregon Health and Science University | Study Director |
| Andrew Nemecek, MD | Oregon Health and Science University | Principal Investigator |
| Deborah Backus, PT, PhD | Shepherd Center, Atlanta GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shepherd Center, Crawford Research Center | Atlanta | Georgia | 30309 | United States | ||
| Oregon Health and Science University |
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| ID | Title | Description |
|---|---|---|
| FG000 | AMES Treatment | 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. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AMES Treatment | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gait Velocity | Measured by the GAITRite system | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMES Treatment | 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. 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). |
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The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Cordo | AMES Technology Inc. | 15039706129 | pcordo@amesdevices.com |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| Timed 10-Meter Walk Test | 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 | 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. | 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 . | Prior to each treatment session, on average 3 times a week |
| ASIA Motor and Sensory Scores for L2-S1 | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
| Portland |
| Oregon |
| 97239 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Vibration Threshold Test | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
|
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| Secondary | Modified Ashworth Scale | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
|
|
| Secondary | Timed 10-Meter Walk Test | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
|
|
| Secondary | Gait Assessment Including Step Length and Cadence | Measured by the GAITRite system | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
|
|
| Secondary | 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. | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Prior to each treatment session, on average 3 times a week |
|
|
| Secondary | Ankle Strength | The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction . | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Prior to each treatment session, on average 3 times a week |
|
|
| Secondary | ASIA Motor and Sensory Scores for L2-S1 | The study was not funded and, therefore, enrollment was terminated and the data were not analyzed. | Posted | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). |
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| 0 |
| 2 |
| 0 |
| 2 |
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| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |