Spinal Cord InjuriesPhase 2EXTra-SCINCT03410550
Exoskeleton and Spinal Cord Injury
A Phase 2 study testing Exoskeleton Training in people with Spinal Cord Injuries, run by McGuire Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Exoskeleton Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Exoskeleton Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton TrainingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton Training | Experimental | Twenty men with complete and incomplete SCI will be enrolled in the trial. Receives: Device: Exoskeleton Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (mmHg)
Resting blood pressure and post-exercise blood pressure will be measured every visit.
Measured: 12 weeks
Walking time (minutes)
The robotic unit will measure standing up time, walking time and walking distance for every visit.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (5)
Six minute-walk Test (meter)
The test will competed at the beginning and at the end of study to measure distance.
Measured: 12 weeks
Walking Index for Spinal Cord Injury II (WISCI II)
The test will competed at the beginning and at the end of study
Measured: 12 weeks
Electromyography (EMG) activity of 6 muscle groups (mV)
The test will competed at the beginning and at the end of study
Measured: 12 weeks
Mitochondrial health using near infra-red spectroscopy (seconds)
The test will competed at the beginning and at the end of study
Measured: 12 weeks
10 meter walk Test (m/sec)
The test will competed at the beginning and at the end of study to measure speed.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Jul 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGuire Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Gorgey, McGuire Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410550
- Sponsor's protocol ID
- 02375
- Acronym
- EXTra-SCI
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2018
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeleton Training After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03410550
- Acronym / sponsor ID
- EXTra-SCI / 02375
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGuire Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton Training | Experimental | Device: Exoskeleton TrainingTwenty men with complete and incomplete SCI will be enrolled in the trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton TrainingTwenty 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). | Device | Exoskeleton Training |
Primary outcome
Blood Pressure (mmHg)
Time frame: 12 weeks
Resting blood pressure and post-exercise blood pressure will be measured every visit.
Walking time (minutes)
Time frame: 12 weeks
The robotic unit will measure standing up time, walking time and walking distance for every visit.
Oxygen uptake (l/min)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Six minute-walk Test (meter)
Time frame: 12 weeks
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: 12 weeks
Electromyography (EMG) activity of 6 muscle groups (mV)
Time frame: 12 weeks
Mitochondrial health using near infra-red spectroscopy (seconds)
Time frame: 12 weeks
10 meter walk Test (m/sec)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exoskeleton Training in people with Spinal Cord Injuries, run by McGuire Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (mmHg) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.