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Exoskeleton and Spinal Cord Injury (EXTra-SCI)

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exoskeleton Training
Sponsored by
McGuire Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exoskeleton Training

Arm Description

Twenty men with complete and incomplete SCI will be enrolled in the trial.

Outcomes

Primary Outcome Measures

Blood Pressure (mmHg)
Resting blood pressure and post-exercise blood pressure will be measured every visit.
Walking time (minutes)
The robotic unit will measure standing up time, walking time and walking distance for every visit.
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.
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.

Secondary Outcome Measures

Six minute-walk Test (meter)
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)
The test will competed at the beginning and at the end of study
Electromyography (EMG) activity of 6 muscle groups (mV)
The test will competed at the beginning and at the end of study
Mitochondrial health using near infra-red spectroscopy (seconds)
The test will competed at the beginning and at the end of study
10 meter walk Test (m/sec)
The test will competed at the beginning and at the end of study to measure speed.

Full Information

First Posted
January 11, 2018
Last Updated
February 1, 2022
Sponsor
McGuire Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03410550
Brief Title
Exoskeleton and Spinal Cord Injury
Acronym
EXTra-SCI
Official Title
Exoskeleton Training After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGuire Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton Training
Arm Type
Experimental
Arm Description
Twenty men with complete and incomplete SCI will be enrolled in the trial.
Intervention Type
Device
Intervention Name(s)
Exoskeleton Training
Intervention 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).
Primary Outcome Measure Information:
Title
Blood Pressure (mmHg)
Description
Resting blood pressure and post-exercise blood pressure will be measured every visit.
Time Frame
12 weeks
Title
Walking time (minutes)
Description
The robotic unit will measure standing up time, walking time and walking distance for every visit.
Time Frame
12 weeks
Title
Oxygen uptake (l/min)
Description
Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.
Time Frame
12 weeks
Title
Body Composition (kg)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Six minute-walk Test (meter)
Description
The test will competed at the beginning and at the end of study to measure distance.
Time Frame
12 weeks
Title
Walking Index for Spinal Cord Injury II (WISCI II)
Description
The test will competed at the beginning and at the end of study
Time Frame
12 weeks
Title
Electromyography (EMG) activity of 6 muscle groups (mV)
Description
The test will competed at the beginning and at the end of study
Time Frame
12 weeks
Title
Mitochondrial health using near infra-red spectroscopy (seconds)
Description
The test will competed at the beginning and at the end of study
Time Frame
12 weeks
Title
10 meter walk Test (m/sec)
Description
The test will competed at the beginning and at the end of study to measure speed.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A written clearance by the medical doctor . Participants will have to be 1 year post-injury with any level of injury. All participants will be between 18-70 years old, men/women, Exclusion Criteria: Participants with body weight greater than 220 lbs Whole body T-scores less than -2.5 standard deviation will result in elimination from the program. Hip width, upper leg length and lower leg length that do not fit in the robotic suit. Previous unhealed fracture in both lower or upper extremities Leg length discrepancy that is unlikely to be managed by having shoe inserts High resting blood pressure greater than 130/80 mmHg Sudden drop in blood pressure by 20 mmHg especially in persons with tetraplegia. 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. Pregnancy
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.frontiersin.org/articles/10.3389/fresc.2021.789422/full
Description
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Exoskeleton and Spinal Cord Injury

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