Spinal Cord InjuriesNCT04013997
Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
A study testing EksoGT in people with Spinal Cord Injuries and Inpatients, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
To assess how safe the exoskeleton, EksoGT, is to use for acute inpatient rehabilitation, if it helps people to walk better than with traditional walking training methods, or if they have any other effects (better or worse) on recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Inpatients
- What is being tested?
- EksoGT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 12 Jun 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater
- Height between 5'2" and 6'2" (1.6 meters to 1.9 meters)
- Weight less than 220 pounds (100 kilograms)
- Near Normal range of motion (ROM), as follows:
- Hip: 5 degrees of extension; 110 of flexion
- Knee: Full extension to 110 of flexion
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- Ankle: at least 0 of dorsiflexion to 25 of plantarflexion
- Are eligible for locomotor training as part of inpatient rehabilitation
- Independent with static sitting balance
- Sufficient function upper extremity strength to manage walking aid (front-wheeled walker, platform walker, or crutches)
- Able to follow directions
Who cannot join
- Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension)
- Inability to stand upright due to orthostatic hypotension
- Body characteristics that do not fit within exoskeleton limits
- Upper leg length discrepancy > 0.5" or lower leg discrepancy >0.75"
- Skin integrity issues in areas that would contact the device or that would likely be made worse by device use
- Pregnancy
Show all 10Show fewer
- Colostomy
- Non-English Speaking
- The participant is able to walk better with exoskeleton assistance at baseline
- Any other issue that might prevent safe standing or walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
To assess how safe the exoskeleton, EksoGT, is to use for acute inpatient rehabilitation, if it helps people to walk better than with traditional walking training methods, or if they have any other effects (better or worse) on recovery.
Read the detailed description
Wearable robots that assist with walking over ground are now available in rehabilitation centers. However, the study team did not know how soon it is safe to start using these devices for rehabilitation, if they helped people to walk better than with traditional locomotor training methods, or if they had any other effects (better or worse) on recovery.
The study team's objectives of this study were to explore the safety, feasibility, and efficacy of using the powered exoskeleton, EksoGT, to provide a locomotor training intervention in acute inpatient rehabilitation for persons with spinal cord injury (SCI) who were eligible for locomotor training.
Aim 1 examined the safety of exoskeleton use for persons with SCI during inpatient rehabilitation. Measures for this aim analyzed the amount of falls as well as types and counts of other adverse events (AE) for both serious and non-serious events as outlined by the FDA.
Aim 2 helped determine the feasibility of exoskeleton use during inpatient rehabilitation for SCI by monitoring the time from admission to first stand in the device, accumulated step count/time in the device, and progression of locomotor training frequency, duration, and intensity.
Aim 3 explored the potential for associations between exoskeleton use in inpatient rehabilitation and body functions and activities associated with walking. Measures for this aim included: American Spinal Injury Association (ASIA) Impairment Scale (AIS), Neurological Level of Injury (NLI), Upper and Lower Extremity Motor Scores, and Functional Index Measure (FIM).
Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians would identify patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants.
After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determines it is safe for participants to begin standing, and continued until the participant is discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living (functioning) compared to the matched control group who didn't have Ekso training and were chosen by a retrospective chart review.
- Conditions
- Spinal Cord Injuries, Inpatients
- Being tested
- EksoGT
- Keywords
- Rehabilitation, Walking, Equipment and Supplies
- 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.
EksoGTDevice
Also called Exoskeletal-assisted walking training
The intervention group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeletal-assisted walking training group | Experimental | Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study. Receives: Device: EksoGT |
| Matched control group | No intervention | Twenty inpatients with SCI were identified as the matched control group through reviewing an acute inpatient rehabilitation database of Uniform Data System for Medical Rehabilitation by a person blinded to the study. The control group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. The control groups received the same amount of acute rehabilitation time per week as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fall
Number of falls to assess safety
Measured: 2 years
Number of adverse events
types and counts of the adverse events for both serious and non-serious events as outlined by the FDA to assess safety
Measured: 2 years
Secondary outcomes (9)
The time from admission to first stand in the device
The days between admission date and the date of first stand in the device
Measured: 2 years
Accumulated step count in the device
The total steps count during the exoskeletal-assisted walking (EAW) training in the acute inpatient rehabilitation
Measured: 2 years
Accumulated step time in the device
The total walking time during the EAW training in the acute inpatient rehabilitation
Measured: 2 years
Proportion of walking time
The change of the proportion of walking time in the device (proportion of walking time = walking time/total time in the device)
Measured: 2 years
American Spinal Injury Association (ASIA) Impairment Scale (AIS)
A: Complete - No motor or sensory function is preserved in the sacral segments S4-S5.
B: Incomplete - Sensory function preserved but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.
C: Incomplete - Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.
D: Incomplete - Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.
E: Normal - Motor and sensory function are normal.
Measured: 2 years
Neurological Level of Injury (NLI)
The NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body
Measured: 2 years
Upper Extremity Motor Scores (UEMS)
Total score from 0-50, with higher score indicating better outcomes
Measured: 2 years
Lower Extremity Motor Scores (LEMS)
Total score from 0-50, with higher score indicating better outcomes
Measured: 2 years
Functional Independence Measure (FIM)
The FIM is an 18-item instrument, total score range from 18-126, with higher score indicating higher level of function
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start11 Aug 2017
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living compared to matched control group who didn't have Ekso training chosen from retrospective chart review.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Escalon, Icahn School of Medicine at Mount Sinai
- Investigators
- Miguel X Escalon, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013997
- Sponsor's protocol ID
- GCO 15-2253
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 10 Jul 2019
- 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT04013997
- Acronym / sponsor ID
- GCO 15-2253
- Conditions
- Spinal Cord Injuries, Inpatients
- Keywords
- Rehabilitation, Walking, Equipment and Supplies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 10 Jul 2019 (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.
To assess how safe the exoskeleton, EksoGT, is to use for acute inpatient rehabilitation, if it helps people to walk better than with traditional walking training methods, or if they have any other effects (better or worse) on recovery.
Detailed description
Wearable robots that assist with walking over ground are now available in rehabilitation centers. However, the study team did not know how soon it is safe to start using these devices for rehabilitation, if they helped people to walk better than with traditional locomotor training methods, or if they had any other effects (better or worse) on recovery.
The study team's objectives of this study were to explore the safety, feasibility, and efficacy of using the powered exoskeleton, EksoGT, to provide a locomotor training intervention in acute inpatient rehabilitation for persons with spinal cord injury (SCI) who were eligible for locomotor training.
Aim 1 examined the safety of exoskeleton use for persons with SCI during inpatient rehabilitation. Measures for this aim analyzed the amount of falls as well as types and counts of other adverse events (AE) for both serious and non-serious events as outlined by the FDA.
Aim 2 helped determine the feasibility of exoskeleton use during inpatient rehabilitation for SCI by monitoring the time from admission to first stand in the device, accumulated step count/time in the device, and progression of locomotor training frequency, duration, and intensity.
Aim 3 explored the potential for associations between exoskeleton use in inpatient rehabilitation and body functions and activities associated with walking. Measures for this aim included: American Spinal Injury Association (ASIA) Impairment Scale (AIS), Neurological Level of Injury (NLI), Upper and Lower Extremity Motor Scores, and Functional Index Measure (FIM).
Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians would identify patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants.
After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determines it is safe for participants to begin standing, and continued until the participant is discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living (functioning) compared to the matched control group who didn't have Ekso training and were chosen by a retrospective chart review.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living compared to matched control group who didn't have Ekso training chosen from retrospective chart review.
| Arm | Type | Receives |
|---|---|---|
| Exoskeletal-assisted walking training group | Experimental | Device: EksoGTProspective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study. |
| Matched control group | No intervention | –Twenty inpatients with SCI were identified as the matched control group through reviewing an acute inpatient rehabilitation database of Uniform Data System for Medical Rehabilitation by a person blinded to the study. The control group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. The control groups received the same amount of acute rehabilitation time per week as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or greater
- Height between 5'2" and 6'2" (1.6 meters to 1.9 meters)
- Weight less than 220 pounds (100 kilograms)
- Near Normal range of motion (ROM), as follows:
- Hip: 5 degrees of extension; 110 of flexion
Key exclusion criteria (10 listed)
- Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension)
- Inability to stand upright due to orthostatic hypotension
- Body characteristics that do not fit within exoskeleton limits
- Upper leg length discrepancy > 0.5" or lower leg discrepancy >0.75"
- Skin integrity issues in areas that would contact the device or that would likely be made worse by device use
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 |
|---|---|---|
| EksoGTAlso: Exoskeletal-assisted walking trainingThe intervention group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation. | Device | Exoskeletal-assisted walking training group |
Primary outcome
Number of fall
Time frame: 2 years
Number of falls to assess safety
Number of adverse events
Time frame: 2 years
types and counts of the adverse events for both serious and non-serious events as outlined by the FDA to assess safety
9 secondary outcomes
The time from admission to first stand in the device
Time frame: 2 years
Accumulated step count in the device
Time frame: 2 years
Accumulated step time in the device
Time frame: 2 years
Proportion of walking time
Time frame: 2 years
American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Time frame: 2 years
Neurological Level of Injury (NLI)
Time frame: 2 years
Upper Extremity Motor Scores (UEMS)
Time frame: 2 years
Lower Extremity Motor Scores (LEMS)
Time frame: 2 years
Functional Independence Measure (FIM)
Time frame: 2 years
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 10 Jul 2019.
- 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.
Miguel X Escalon, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EksoGT in people with Spinal Cord Injuries and Inpatients, run by Icahn School of Medicine at Mount Sinai 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 11 inclusion and 10 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 10 Jul 2019. 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.
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?
Number of fall (time frame: 2 years). The study lists 2 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 10 Jul 2019; AzTrials last refreshed its copy on 5 Nov 2026.