Paraplegia, Quadriplegia, Spinal Cord Injury, Tetraplegia
Conditions
Keywords
Incomplete Spinal Cord Injury, Rehabilitation, AMES device, Lower Extremity, Gait, Paraplegia
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAMES 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).
Sponsors
Shepherd Center, Atlanta GA
National Institute of Neurological Disorders and Stroke (NINDS)
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Paraplegia or tetraplegia due to SCI * At least 1 year post incomplete Spinal Cord Injury * Can tolerate sitting upright for at least one hour * Capable of weight-bearing and taking a step with or without an assistive device * On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5 level * Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for each of these muscles in the qualifying leg
Exclusion criteria
* Fracture of the treated limb resulting in loss of range of motion * Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study), or other neurological injury or disease * DVT of the treated extremity * Peripheral nerve injury of the treated extremity * Osteo- or rheumatoid-arthritis limiting range of motion * Contractures equal to or greater than 50% of the normal ROM * Skin condition not tolerant of device or sitting upright * Progressive neurodegenerative disorder * Botox treatment of the treated extremity in the prior 5 month * Chronic ITB therapy * Uncontrolled seizure disorder * Uncontrolled high blood pressure/angina * Pain in affected limb or exercise intolerance * Participation in another therapy or activity-based program * Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and ankle plantarflexors outside the range of 3-9
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). | Measured by the GAITRite system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | — |
| 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 | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). | Measured by the GAITRite system |
| Ankle Active Motion Test | Prior to each treatment session, on average 3 times a week | 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. |
| Ankle Strength | Prior to each treatment session, on average 3 times a week | The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction . |
| 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). | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | AMES Treatment |
|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 1.5 |
| 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 | 0 / 2 |
Outcome results
Primary
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).
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
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.
Time frame: Prior to each treatment session, on average 3 times a week
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Secondary
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
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Secondary
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).
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Secondary
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).
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Secondary
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).
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Secondary
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).
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.
Secondary
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).
Population: The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.