Spinal Cord Injuries Clinical Trial
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.
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.
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