An interventional study of EksoGT in Spinal Cord Injuries and Inpatients, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Device feasibility
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 10 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
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Exclusion Criteria:
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.
Device: EksoGT
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.
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.
Also known as: Exoskeletal-assisted walking training
Number of fall
Number of falls to assess safety
Time frame: 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
Time frame: 2 years
The time from admission to first stand in the device
The days between admission date and the date of first stand in the device
Time frame: 2 years
Accumulated step count in the device
The total steps count during the exoskeletal-assisted walking (EAW) training in the acute inpatient rehabilitation
Time frame: 2 years
Accumulated step time in the device
The total walking time during the EAW training in the acute inpatient rehabilitation
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 2 years
Upper Extremity Motor Scores (UEMS)
Total score from 0-50, with higher score indicating better outcomes
Time frame: 2 years
Lower Extremity Motor Scores (LEMS)
Total score from 0-50, with higher score indicating better outcomes
Time frame: 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
Time frame: 2 years
Plan to share: No
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Icahn School of Medicine at Mount Sinai