Clinical trial NCT03410550: Exoskeleton and Spinal Cord Injury
Official title: Exoskeleton Training After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injuries
Lead sponsor: McGuire Research Institute
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.

Detailed description: Powered exoskeletons using robotic suits have recently been introduced for the rehabilitation of persons with spinal cord injury (SCI). Exoskeletons offer a unique opportunity for persons with SCI to experience standing and walking at a low metabolic cost. Evidence suggested that exoskeleton assisted walking can decrease spasticity and improve bowel movement. Training may also improve the level of physical activity as well as psychological parameters that are likely to interfere with rehabilitation outcomes. Previous studies reported that a frequency of 2-3 times per week or more for 1-2 hours may be beneficial in the rehabilitation of persons with SCI. Using exoskeletal-assisted walking to improve the level of physical activity may be appealing to persons with SCI.

Exoskeleton training for 12 weeks may enhance energy expenditure, parameters of physical activity and result only on modest effects on both cardiovascular and body composition parameters. In other words, persons with tetraplegia may have greater cardiovascular and body composition adaptations compared to persons with paraplegia. Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.

Eligibility criteria: Inclusion Criteria:

1. A written clearance by the medical doctor .
2. Participants will have to be 1 year post-injury with any level of injury.
3. All participants will be between 18-70 years old, men/women,

Exclusion Criteria:

1. Participants with body weight greater than 220 lbs
2. Whole body T-scores less than -2.5 standard deviation will result in elimination from the program.
3. Hip width, upper leg length and lower leg length that do not fit in the robotic suit.
4. Previous unhealed fracture in both lower or upper extremities
5. Leg length discrepancy that is unlikely to be managed by having shoe inserts
6. High resting blood pressure greater than 130/80 mmHg
7. Sudden drop in blood pressure by 20 mmHg especially in persons with tetraplegia.
8. Medical conditions prior enrollment similar to cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, pressures sores stage 2 or greater, or urinary tract infection or symptoms.
9. Pregnancy

Primary outcomes:
measure: Blood Pressure (mmHg)
timeFrame: 12 weeks
measure: Walking time (minutes)
timeFrame: 12 weeks
measure: Oxygen uptake (l/min)
timeFrame: 12 weeks
measure: Body Composition (kg)
timeFrame: 12 weeks
Secondary outcomes:
measure: Six minute-walk Test (meter)
timeFrame: 12 weeks
measure: Walking Index for Spinal Cord Injury II (WISCI II)
timeFrame: 12 weeks
measure: Electromyography (EMG) activity of 6 muscle groups (mV)
timeFrame: 12 weeks
measure: Mitochondrial health using near infra-red spectroscopy (seconds)
timeFrame: 12 weeks
measure: 10 meter walk Test (m/sec)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
References: