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The purpose of the current study is to determine the effects of applying epidural stimulation (ES) on motor control recovery in Veterans with SCI. The intervention will be accompanied with the use of a powered exoskeleton (EKSO®) for 6 months to facilitate standing and to produce step-like movement in persons with chronic motor complete (AIS A or B) SCI and level of injury below C5 . Walking speed, distance, muscle activation pattern as measured by surface EMG and walking parameters including stand-up time, walking time, distance will be considered primary outcome variables. Cardiovascular performance, as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments will also be measured. The effects of training (ES+EKSO) on , and speed of walking will also be evaluated.
Five veterans with chronic motor complete SCI (AIS A or B) will be recruited to participate in the current trial. The primary objective is to determine how implantation of an epidural stimulator can help to control movement in the leg muscles to stand and perform stepping. Participants will be trained using a robotic suit and parallel bars. The procedure of using epidural stimulation with the robotic suit is experimental. The participant will be scheduled to perform temporary implantation followed by permanent implantation. Seven days later, two 8-electrode arrays of Vectris lead will be implanted in an operating room. The research team will be responsible for helping the participants to trigger the paralyzed muscles from supine and sitting using for 5 days per week. Participants would be required to come for study visits twice daily for 2 hours per day. Each visit will last approximately 1 hour in the morning and 1 hour in the evening. During these visits, participants will practice walking with a robotic suit for 30-60 minutes followed by overground walking between parallel bars, or with a walker or crutches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EKSO+ES | Experimental | 6 months of exoskeleton training with spinal cord epidural stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EKSO+ES | Device | 6 months of exoskeleton training with epidural stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Six minute-walk and 10-meter walk distance Tests | Walking distance and speed will also be determined | 6 months |
| Surface electromyography of 6 different muscle groups | The EMG activity from 6 major leg muscles will be measured during locomotion | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and Diastolic Blood Pressure | During sitting, standing and walking | 6 months |
| Oxygen uptake using Portable Indirect Calorimetry | During sitting, standing and walking |
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Inclusion Criteria:
Exclusion Criteria:
Unhealed fracture in either lower or upper extremities
Severe scoliosis, hip knee ROM or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion deformity greater than 20 degrees.
High resting blood pressure greater than 140/80 mmHg and or sudden hypotension upon standing as characterized by drop in blood pressure by 20 mmHg especially in persons with tetraplegia.
Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection.
Unable to fit in the device for any reason.
Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
Implanted pacemakers and/or implanted defibrillator devices.
Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and/or increases the risk of infection.
Dual Energy X-ray Absorptiometry (DXA) T-Score less than -2.5. Scans done will include total body, dual hips and knees.
Functional upper and lower extremity range of motion (ROM), strength, spasticity and skin integrity will also have assessed prior to enrollment in the program. The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program. Participants with severe spasticity or limited ROM will be excluded in the trial. This will be done based on the manufacture's recommendation.
Other exclusion criteria may include the followings
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashraf S Gorgey, PhD | Contact | 8046755000 | 3386 | ashraf.gorgey@va.gov |
| Robert Trainer, MD | Contact | Robert.Trainer@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ashraf S Gorgey, PhD | Hunter Holmes McGuire VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
IPD will be available in the form of published case reports as well as scientific presentations in national and international meetings.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 6 months |
| Body composition assessment of fat mass and fat-free mass using dual energy x-ray absorptiometry (DXA) | Before and after training | 6 months |
| D014947 | Wounds and Injuries |