Exoskeleton and Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— EXTra-SCI  

Official title:

Exoskeleton Training After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410550
• Other study ID #: 02375
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: McGuire Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
McGuire Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure (mmHg)	Resting blood pressure and post-exercise blood pressure will be measured every visit.	12 weeks
Primary	Walking time (minutes)	The robotic unit will measure standing up time, walking time and walking distance for every visit.	12 weeks
Primary	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
Primary	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	Six minute-walk Test (meter)	The test will competed at the beginning and at the end of study to measure distance.	12 weeks
Secondary	Walking Index for Spinal Cord Injury II (WISCI II)	The test will competed at the beginning and at the end of study	12 weeks
Secondary	Electromyography (EMG) activity of 6 muscle groups (mV)	The test will competed at the beginning and at the end of study	12 weeks
Secondary	Mitochondrial health using near infra-red spectroscopy (seconds)	The test will competed at the beginning and at the end of study	12 weeks
Secondary	10 meter walk Test (m/sec)	The test will competed at the beginning and at the end of study to measure speed.	12 weeks

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