Exoskeleton and Spinal Cord Injury (EXTra-SCI)

Exoskeleton Training After Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Exoskeleton Training

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exoskeleton Training; Twenty men with complete and incomplete SCI will be enrolled in the trial.	Device: Exoskeleton Training; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure (mmHg)	Resting blood pressure and post-exercise blood pressure will be measured every visit.	12 weeks
Walking time (minutes)	The robotic unit will measure standing up time, walking time and walking distance for every visit.	12 weeks
Oxygen uptake (l/min)	Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.	12 weeks
Body Composition (kg)	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.	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McGuire Research Institute

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 02375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No