Exoskeleton and Spinal Cord Injury

Phase 2

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Device: Exoskeleton Training

• Registration Number: NCT03410550
• Lead Sponsor: McGuire Research Institute

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.

Study Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Study Start: 2018-07-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exoskeleton Training	Exoskeleton Training	Twenty men with complete and incomplete SCI will be enrolled in the trial.

Primary Outcome Measures

Name	Time	Method
Blood Pressure (mmHg)	12 weeks	Resting blood pressure and post-exercise blood pressure will be measured every visit.
Walking time (minutes)	12 weeks	The robotic unit will measure standing up time, walking time and walking distance for every visit.
Oxygen uptake (l/min)	12 weeks	Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.
Body Composition (kg)	12 weeks	Body composition using dual energy x-ray absorptiometry anthropometrics' will be measured during sitting, standing and walking at the beginning and at the end of the training program.

Secondary Outcome Measures

Name	Time	Method
Electromyography (EMG) activity of 6 muscle groups (mV)	12 weeks	The test will competed at the beginning and at the end of study
10 meter walk Test (m/sec)	12 weeks	The test will competed at the beginning and at the end of study to measure speed.
Six minute-walk Test (meter)	12 weeks	The test will competed at the beginning and at the end of study to measure distance.
Walking Index for Spinal Cord Injury II (WISCI II)	12 weeks	The test will competed at the beginning and at the end of study
Mitochondrial health using near infra-red spectroscopy (seconds)	12 weeks	The test will competed at the beginning and at the end of study

Trial Locations

Locations (1)

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States